(449 days)
No
The device description and performance studies focus on material properties and mechanical testing, with no mention of AI or ML algorithms for analysis, diagnosis, or treatment.
No.
The device is an implantable component for hip arthroplasty, serving as a replacement part rather than a device for treating a condition directly through therapy.
No
The device is an acetabular shell liner, an implantable component of a total hip arthroplasty system used for surgical reconstruction. Its intended use is to treat existing conditions or replace failed implants, not to diagnose medical conditions.
No
The device description clearly states it is a physical component made of polyethylene, intended for use in total hip arthroplasty, and is subject to extensive non-clinical physical testing.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for the surgical reconstruction of the hip joint. This is a therapeutic and structural purpose, not a diagnostic one.
- Device Description: The description details a physical implant component (an acetabular shell liner) made of polyethylene, designed to be part of a total hip replacement system. This is a medical device used in vivo (within the body), not in vitro (outside the body).
- Lack of Diagnostic Elements: There is no mention of the device being used to test samples (like blood, urine, or tissue) or to provide information about a patient's health status based on such testing.
IVD devices are specifically designed to be used in vitro to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The EXp Acetabular Shell Liner is intended for use in reconstruction of the articulating surface of the acetabular portion of the hip that is severely disabled and/or very painful resulting from:
-
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
-
- Rheumatoid arthritis.
-
- Correction of functional deformity.
-
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
-
- Revision of previously failed total hip Arthroplasty.
Cemented and Uncemented Applications
Product codes
OQG, OQH, OQI, LPH, LWJ, JDI, MAY, LZO
Device Description
The EXp Acetabular Shell Liner is made of polyethylene to which Vitamin E has been added. It is available in both hooded and non-hooded options. The liner is part of a complete total hip system and will be used in conjunction with an acetabular shell, femoral head and femoral stem in total hip arthroplasty. The femoral heads which are to be mated with the EXp Liner are made of Biolox forte, Biolox Delta, or CoCr alloy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Acetabular portion of the hip, proximal femur
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing was performed on the EXp Acetabular Liner to determine tensile strength, impact strength, compressive strength, small punch strength, thermal properties, free radical concentration. oxidation resistance, swell ratio, hip simulator wear under normal and abrasive conditions, wear particle characterization, rim impingement, liner push-out, lever-out, and torque-out resistance, GCMS analysis of hexane extract postwear testing, fusion defect characterization, fatigue crack propagation, trans-vinylene index, and biocompatibility (i.e., mutagenicity, irritation, sensitization, and cytotoxicity testing).
The results of the performed tests demonstrate that the EXp Acetabular Liner is substantially equivalent to legally marketed predicate devices.
Claims for the EXp Liner:
-
EXp is more resistant to oxidation than conventional UHMWPE and its ultimate load, as measured per ASTM F2183, does not decrease during oxidative aging per ASTM F2003, The EXp UHMWPE is a compression molded GUR 1020 blended with Vitamin E. crosslinked with gamma irradiation and terminally sterilized using ethylene oxide. For comparison, a well recognized industry standard material, conventional GUR 1050 material, sterilized using 25kGy in an inert environment was tested in parallel. The EXp UHMWPE demonstrated resistance to oxidation, as measured using ASTM F2102, after aging per ASTM F2003. Specifically, after four weeks of aging per ASTM F2003, the maximum ASTM F2102 oxidation index increased from 0.1 +/- 0.02 to 0.2 for the EXp material and from 0.1 +/- 0.04 to 3.8 +/- 0.2 for the conventional GUR1050 material. Consistent with the oxidation index data, the resulting mechanical performance of the materials, as determined using the ASTM F2183 small punch test. showed that the EXp material retained its mechanical performance while that of the 25kGv GUR 1050 material decreased. Specifically, the ultimate load for the EXp material remained relatively constant. 63.3 +/- 8.9 N and 73.1 +/- 5.2 N. for the non-aged and 4-week-aged material, respectively. The ultimate load for the conventional material decreased from 71.5 +/- 3.0 N for the non-aged material to an embrittled condition in which no small punch sample could be machined. For reference, the ultimate load after two weeks of aging had reduced to 45.7 +/- 5.9 N.
-
The morphology of the EXp UHMWPE is consistent with conventional UHMWPE. Material samples of both the EXp UHMWPE and 25kGy GUR 1050 material were subjected to freeze fracture analysis. Both materials demonstrated no consolidation defects or voids when imaged at high magnification under scanning electron microscopy.
-
The vitamin E blended into the EXp UHMWPE does not elute from the EXp material during hexane extraction or isopropanol (IPA) extraction. Gas chromatography-mass spectrometry (GC-MS) and liquid chromatography -mass spectrometry (LC-MS) analysis of hexane solvent used for extraction of the EXp material confirmed that no Vitamin E was extracted from the material when refluxed at 74°C for 24 hours. GC-MS and LC-MS analysis of IPA solvent used for extraction of the EXp material confirmed that no Vitamin E was extracted from the material when soaked at room temperature for 18 hours. The GC-MS and LC-MS technique have detection limits of 50-250 ppb and 1000 ppm, respectively.
-
EXpremains resistant to oxidation after 5 million cycles of wear testing and artificial aging. Wear testing followed by accelerated aging provides a method to assess the possibility that repeated loading experienced during wear testing may change the distribution or content of the Vitamin E in the EXp material; leaving the material susceptible to oxidation. Testing was conducted per ISO 14242-1 using an AMTI hip simulator with 20g/L bovine serum lubricant to a total cycle count of 5.0 million cycles. All samples were tested in their final sterilized form. Following wear testing, the EXp Liners were aged in an oxidative environment per ASTM F2003 for 4 weeks. The EXp Liners demonstrated a resistance to oxidation, as measured using ASTM F2102. Specifically, the maximum oxidation index increased from 0.1 +/- 0.02 for the non-aged EXp material to 0.2 +/- 0.02 for the four-week-aged EXp material.
-
The EXp liners experienced no failures as a result of dynamic impingement testing. Dynamic impingement testing, per ASTM F2582, confirmed that artificially aged EXp liners demonstrated a resistance to rim fracture under fatigue loading conditions to 1.0MC. Specifically, three liners were loaded to engage the liner rim with the femoral neck at moments equal to 4.6 Nm (70% of the static peak dislocation moments). All three samples reached run-out equal to 1.0MC and no fractures of the liners were observed throughout testing nor did the locking mechanism fail.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K935484, K950827, K032396, K970501, K050327
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K083762, K073102, K071535, K051588, P040051, K934162
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.
0
510(k) Summary
| Manufacturer: | StelKast, Inc.
200 Hidden Valley Road
McMurray, PA 15317 | MAR 2 4 2011 |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Device Trade Name: | EXp Acetabular Shell Liner | |
| Contact: | Mr. Donald A. Stevens
Vice Chairman
(888) 273-1583 | |
| Prepared by: | Musculoskeletal Clinical Regulatory Advisers, LLC
1331 H Street, NW, 12th Floor
Washington, DC 20005
Phone: (202)552-5800 | |
| Date Prepared: | March 14, 2011 | |
| Common Name: | Acetabular Shell Liner | |
| Classification: | 21 CFR 888.3358, Hip joint metal/polymer/metal semiconstrained
porous-coated uncemented prosthesis | |
| Class: | II | |
| Product Codes: | OQG, OQH, OQI, LPH, LWJ, JDI, MAY, LZO | |
Indications For Use:
The EXp Acetabular Shell Liner is intended for use in reconstruction of the articulating surface of the acetabular portion of the hip that is severely disabled and/or very painful resulting from:
-
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
-
- Rheumatoid arthritis.
-
- Correction of functional deformity.
-
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
-
- Revision of previously failed total hip Arthroplasty.
Cemented and Uncemented Applications
1
Device Description:
The EXp Acetabular Shell Liner is made of polyethylene to which Vitamin E has been added. It is available in both hooded and non-hooded options. The liner is part of a complete total hip system and will be used in conjunction with an acetabular shell, femoral head and femoral stem in total hip arthroplasty. The femoral heads which are to be mated with the EXp Liner are made of Biolox forte, Biolox Delta, or CoCr alloy.
Predicate Devices:
Liners
Comparative information presented in the 510(k) supports the substantial equivalence of the EXp Acetabular Liner with respect to its indications for use, design, materials, and function.
This 510(k) demonstrates the substantial equivalence of the EXp Acetabular Liner to the following predicate devices: Acetabular Liners in the Stelkast Provident Hip System (K935484) and the Stelkast ProForm Hip System (K950827); Biomet RingLoc Acetabular Component with ArCom Polyethylene (K032396 and K970501). Previously cleared polyethylene acetabular liners to which Vitamin E has been added include the Biomet E-Poly (Vitamin E) Acetabular Liners (K050327).
All of these acetabular liners have the same intended use, have the same general design and available sizes, and are made of UHMWPE.
Non-clinical testing was performed on the EXp Acetabular Liner to determine tensile strength, impact strength, compressive strength, small punch strength, thermal properties, free radical concentration. oxidation resistance, swell ratio, hip simulator wear under normal and abrasive conditions, wear particle characterization, rim impingement, liner push-out, lever-out, and torque-out resistance, GCMS analysis of hexane extract postwear testing, fusion defect characterization, fatigue crack propagation, trans-vinylene index, and biocompatibility (i.e., mutagenicity, irritation, sensitization, and cytotoxicity testing).
The results of the performed tests demonstrate that the EXp Acetabular Liner is substantially equivalent to legally marketed predicate devices.
Femoral Heads
The StelKast Biolox Delta Ceramic Femoral heads are substantially equivalent to previously cleared Biolox Delta Ceramic Femoral Heads: Smith & Nephew (K083762); Biomet (K073102); Zimmer (K071535); and Howmedica Osteonics (K051588). The StelKast Biolox forte Ceramic Femoral Heads were approved for use with StelKast femoral stems in P040051. The CoCr Femoral Heads were cleared for use with StelKast femoral stems in K934162.
Testing in support of the ceramic femoral heads includes static burst strength, fatigue, post-fatigue burst strength, pull-off, and rotational stability.
2
Claims for the EXp Liner
Oxidative Stability and Mechanical Performance of the EXp material
-
- EXp is more resistant to oxidation than conventional UHMWPE and its ultimate load, as measured per ASTM F2183, does not decrease during oxidative aging per ASTM F2003, The EXp UHMWPE is a compression molded GUR 1020 blended with Vitamin E. crosslinked with gamma irradiation and terminally sterilized using ethylene oxide. For comparison, a well recognized industry standard material, conventional GUR 1050 material, sterilized using 25kGy in an inert environment was tested in parallel. The EXp UHMWPE demonstrated resistance to oxidation, as measured using ASTM F2102, after aging per ASTM F2003. Specifically, after four weeks of aging per ASTM F2003, the maximum ASTM F2102 oxidation index increased from 0.1 ± 0.02 to 0.2 for the EXp material and from 0.1 ± 0.04 to 3.8 ± 0.2 for the conventional GUR1050 material.
Consistent with the oxidation index data, the resulting mechanical performance of the materials, as determined using the ASTM F2183 small punch test. showed that the EXp material retained its mechanical performance while that of the 25kGv GUR 1050 material decreased. Specifically, the ultimate load for the EXp material remained relatively constant. 63.3 ± 8.9 N and 73.1 ± 5.2 N. for the non-aged and 4-week-aged material, respectively. The ultimate load for the conventional material decreased from 71.5 ± 3.0 N for the non-aged material to an embrittled condition in which no small punch sample could be machined. For reference, the ultimate load after two weeks of aging had reduced to 45.7 ± 5.9 N.
- EXp is more resistant to oxidation than conventional UHMWPE and its ultimate load, as measured per ASTM F2183, does not decrease during oxidative aging per ASTM F2003, The EXp UHMWPE is a compression molded GUR 1020 blended with Vitamin E. crosslinked with gamma irradiation and terminally sterilized using ethylene oxide. For comparison, a well recognized industry standard material, conventional GUR 1050 material, sterilized using 25kGy in an inert environment was tested in parallel. The EXp UHMWPE demonstrated resistance to oxidation, as measured using ASTM F2102, after aging per ASTM F2003. Specifically, after four weeks of aging per ASTM F2003, the maximum ASTM F2102 oxidation index increased from 0.1 ± 0.02 to 0.2 for the EXp material and from 0.1 ± 0.04 to 3.8 ± 0.2 for the conventional GUR1050 material.
All EXp samples were machined from GUR1020- E. which is blended by percentage weight with Vitamin E. compression molded, crosslinked with gamma irradiation, and subsequently ethylene oxide sterilized. All conventional samples were machined from GUR1050, ram extruded UHMWPE and subsequently gamma sterilized using 25-40 kGv in an inert environment. Bench testing is not necessarily indicative of clinical performance.
-
- The morphology of the EXp UHMWPE is consistent with conventional UHMWPE. Material samples of both the EXp UHMWPE and 25kGy GUR 1050 material were subjected to freeze fracture analysis. Both materials demonstrated no consolidation defects or voids when imaged at high magnification under scanning electron microscopy.
All EXp samples were machined from GUR1020- E, which is blended by percentage weight with Vitamin E, compression molded, crosslinked with gamma irradiation, and subsequently ethylene oxide sterilized. All conventional samples were machined from GUR1050, ram extruded UHMWPE and subsequently gamma sterilized using 25-40 kGy in an inert environment. Bench testing is not necessarily indicative of clinical performance.
- The morphology of the EXp UHMWPE is consistent with conventional UHMWPE. Material samples of both the EXp UHMWPE and 25kGy GUR 1050 material were subjected to freeze fracture analysis. Both materials demonstrated no consolidation defects or voids when imaged at high magnification under scanning electron microscopy.
-
- The vitamin E blended into the EXp UHMWPE does not elute from the EXp material during hexane extraction or isopropanol (IPA) extraction. Gas chromatography-mass spectrometry (GC-MS) and liquid chromatography -mass spectrometry (LC-MS) analysis of hexane solvent used for extraction of the EXp material confirmed that no Vitamin E was extracted from the material when refluxed at 74°C for 24 hours. GC-MS and LC-MS analysis of IPA solvent used for extraction of the EXp material confirmed
3
that no Vitamin E was extracted from the material when soaked at room temperature for 18 hours. The GC-MS and LC-MS technique have detection limits of 50-250 ppb and 1000 ppm, respectively.
All EXp samples were machined from GUR1020- E. which is blended by percentage weight with Vitamin E, compression molded, crosslinked with gamma irradiation, and subsequently ethylene oxide sterilized. Bench testing is not necessarily indicative of clinical performance.
Oxidative Stability and Mechanical Performance of the EXp Liners
-
- EXpremains resistant to oxidation after 5 million cycles of wear testing and artificial aging. Wear testing followed by accelerated aging provides a method to assess the possibility that repeated loading experienced during wear testing may change the distribution or content of the Vitamin E in the EXp material; leaving the material susceptible to oxidation. Testing was conducted per ISO 14242-1 using an AMTI hip simulator with 20g/L bovine serum lubricant to a total cycle count of 5.0 million cycles. All samples were tested in their final sterilized form. Following wear testing, the EXp Liners were aged in an oxidative environment per ASTM F2003 for 4 weeks. The EXp Liners demonstrated a resistance to oxidation, as measured using ASTM F2102. Specifically, the maximum oxidation index increased from 0.1 ± 0.02 for the non-aged EXp material to 0.2 ± 0.02 for the four-week-aged EXp material.
EXp samples were machined from GUR1020- E, which is blended by percentage weight with Vitamin E, compression molded, crosslinked with gamma irradiation, and subsequently ethylene oxide sterilized. Bench testing is not necessarily indicative of clinical performance.
- EXpremains resistant to oxidation after 5 million cycles of wear testing and artificial aging. Wear testing followed by accelerated aging provides a method to assess the possibility that repeated loading experienced during wear testing may change the distribution or content of the Vitamin E in the EXp material; leaving the material susceptible to oxidation. Testing was conducted per ISO 14242-1 using an AMTI hip simulator with 20g/L bovine serum lubricant to a total cycle count of 5.0 million cycles. All samples were tested in their final sterilized form. Following wear testing, the EXp Liners were aged in an oxidative environment per ASTM F2003 for 4 weeks. The EXp Liners demonstrated a resistance to oxidation, as measured using ASTM F2102. Specifically, the maximum oxidation index increased from 0.1 ± 0.02 for the non-aged EXp material to 0.2 ± 0.02 for the four-week-aged EXp material.
-
- The EXp liners experienced no failures as a result of dynamic impingement testing. Dynamic impingement testing, per ASTM F2582, confirmed that artificially aged EXp liners demonstrated a resistance to rim fracture under fatigue loading conditions to 1.0MC. Specifically, three liners were loaded to engage the liner rim with the femoral neck at moments equal to 4.6 Nm (70% of the static peak dislocation moments). All three samples reached run-out equal to 1.0MC and no fractures of the liners were observed throughout testing nor did the locking mechanism fail.
All EXp samples were machined from GUR1020- E, which is blended by percentage weight with Vitamin E, compression molded, crosslinked with gamma irradiation, and subsequently ethylene oxide sterilized. Bench testing is not necessarily indicative of clinical performance.
- The EXp liners experienced no failures as a result of dynamic impingement testing. Dynamic impingement testing, per ASTM F2582, confirmed that artificially aged EXp liners demonstrated a resistance to rim fracture under fatigue loading conditions to 1.0MC. Specifically, three liners were loaded to engage the liner rim with the femoral neck at moments equal to 4.6 Nm (70% of the static peak dislocation moments). All three samples reached run-out equal to 1.0MC and no fractures of the liners were observed throughout testing nor did the locking mechanism fail.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
StelKast, Inc. % Mr. Donald A. Stevens Vice Chairman 200 Hidden Valley Road McMurray, Pennsylvania 15317
MAR 2 4 2011
Re: K094035 Trade/Device Name: EXp Acetabular Shell Liner Regulation Number: 21 CFR 888.3358 Regulation Name: Hip Joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: OQG, OQH, OQI, LPH, LWJ, JDI, MAY, LZO Dated: March 15, 2011 Received: March 17, 2011
Dear Mr. Stevens:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the includions for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drig, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act The general controls provisions of the Act include requirements for annual registration, inte re of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not maching.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your devine can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
5
Page 2 - Mr. Donald A. Stevens
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements not the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and Issing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803), good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 100-100.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115801.html for the Center for Devices and Radiological Health's (CDRH's) Office of Cochilian 1962.1000 roll note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.h1m for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll the (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Aty B. Ruter
for
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known):
Device Name: EXp Acetabular Liner
Indications for Use:
-
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
-
- Rheumatoid arthritis.
-
- Correction of functional deformity.
-
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
-
- Revision of previously failed total hip Arthroplasty.
Cemented and Uncemented Applications
Prescription Use YES AND/OR Over-The-Counter Use NO
(Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
for M. Mulkerson
(Division Sign-Offy Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K094035 Page j of 1