(63 days)
Not Found
No
The document describes a family of bio-composite suture anchors and their intended uses in various anatomical locations. The device description focuses on the material composition and similarity to predicate devices, with no mention of software, algorithms, or any technology related to AI or ML.
Yes
The device is intended for the fixation of soft tissue to bone and is used in a variety of surgical procedures to repair or reconstruct tissues, addressing medical conditions. This falls under the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
This device is described as a "Suture Anchor Family" intended for "Fixation of suture (soft tissue) to bone" in various anatomical locations and for surgical procedures, not for identifying or diagnosing medical conditions.
No
The device description clearly states that the device is constructed from bio-degradable material (PLLA or PLDLA combined with TCP), indicating it is a physical implant, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The description and intended use clearly state that this device is a suture anchor used for fixation of suture (soft tissue) to bone in various anatomical locations. This is a surgical implant used directly within the body, not for testing samples outside the body.
The text describes a device used in surgical procedures for musculoskeletal and other repairs, which falls under the category of surgical implants or devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Arthrex Bio-Composite Corkscrew is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and pelvis in, but not limited to, the following procedures: Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction. Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy. Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis. Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction. Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial collateral Ligament Reconstruction, Lateral Epicondylitis Repair. Pelvis: Bladder Neck Suspension for female urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency.
The Arthrex Bio-Composite PushLock™ is intended for fixation of suture (soft tissue) to bone in the shoulder, footlankle, knee, hand/wrist, elbow, and pelvis in the following procedures: Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction. Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy. Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis. Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction. Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair. Pelvis: Bladder Neck Suspension for female urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency.
The Arthrex Bio-Composite Tak™ is intended to be used for suture or tissue fixation in the foot, ankle, knee, hand, wrist, shoulder, elbow, and in select maxillofacial applications. Specific indications are listed below and are size appropriate per patient needs: Stabilization and fixation of oral cranio-maxillofacial skeletal bone, Skull: mandible and maxillofacial bones, Lateral Canthoplasty, Repair of Nasal Vestibular Stenosis, Brow Lift, Temporomandibular Joint (TMJ) reconstruction, Soft tissue attachment to the parietal temporal ridge, frontal, zygoma, and perioorbital bones of the skull. Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Elbow. Reconstruction. Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Shoulder: Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction. Scapholunate Ligament Reconstruction, Carpal Ligament Hand/Wrist: Reconstruction, Repair/Reconstruction of Collateral Ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, Digital Tendon Transfers. Foot/Ankle. Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus Reconstruction, Digital Tendon Transfers, Mid-foot reconstruction, Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis. Pelvis: Bladder Neck Suspension for female urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency.
Product codes (comma separated list FDA assigned to the subject device)
HWC, MBI, JDR, MAI
Device Description
The Arthrex Bio-Composite Suture Anchors Family is very similar to the predicate devices in diameter, length, and eyelet design. The difference lies in the bio-degradable material used to construct the new model. The implants will use PLLA or PLDLA combined with TCP.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, foot/ankle, knee, hand/wrist, elbow, pelvis, maxillofacial
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)
Not Found
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.
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.
Not Found
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
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
Ko 7/1/77 Psa 1/4
Arthrex SPECIAL 510(K): Arthrex Bio-Composite Suture Anchors
JUN 2 9 2007
2 510(k) Summary of Safety and Effectiveness
| Manufacturer/Sponsor | Arthrex, Inc.1370 Creekside Boulevard Naples, Florida 34108-1945 |
|---|---|
| 510(k) Contact | Mariela Cabarcas |
| Regulatory Affairs Associate | |
| Telephone: 239/643.5553, ext 1246 | |
| Fax: 239/598.5508 | |
| Email: mcabarcas@arthrex.com | |
| Trade Name | Arthrex Bio-Composite Suture Anchors: Arthrex Bio-Composite |
| PushLock, Bio-Composite Tak and Bio-Composite Corkscrew. | |
| Common Name | Suture Anchor. |
| Product Code - | |
| Classification Name | HWC - Screw, Fixation, Bone |
| MBI - Fastener, Fixation, Nondegradable Soft Tissue | |
| JDR - Staple, fixation, bone | |
| MAI - Fastener, Fixation, Biodegradable, Soft Tissue | |
| Predicate Device | Arthrex PushLock, Tak and Corkscrew Suture Anchors: K061863 |
| Device Description | |
| and Intended Use | The Arthrex Bio-Composite Suture Anchors Family is very similar to |
| the predicate devices in diameter, length, and eyelet design. The | |
| difference lies in the bio-degradable material used to construct the new | |
| model. The implants will use PLLA or PLDLA combined with TCP. | |
| The Arthrex Bio-Composite Suture Anchor Family is intended to be | |
| used for: | |
| Fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, | |
| knee, hand/wrist, elbow, and pelvis. | |
| For suture or tissue fixation in the foot, ankle, hand, wrist, elbow, | |
| shoulder, and in select maxillofacial applications where size is | |
| appropriate. | |
| Please see indications for use statements for specific indications. | |
| Substantial | |
| Equivalence Summary | The Arthrex Bio-Composite Suture Anchor Family is substantially |
| equivalent to the predicate Arthrex PushLock, Tak and Corkscrew Suture | |
| Anchors families in which the basic features and intended uses are identical | |
| except for the exclusion of the hip indication. The Bio-Composite Suture | |
| Anchors are not indicated to be used for the capsular and acetabular labral | |
| repair. | |
| Any differences between the Bio-Composite Suture Anchor Family and the | |
| predicate K061863 are considered minor and do not raise questions | |
| concerning safety and effectiveness. Based on the information submitted, | |
| Arthrex, Inc. has determined that the new Bio-Composite Suture Anchor | |
| Family is substantially equivalent to the currently marketed predicate device. |
1
3 Substantial Equivalence
The fundamental scientific technology of the Arthrex Bio-Composite Suture Anchors has not changed from the previously cleared Suture Anchor Family, K061863.
The indications for use of the Arthrex Bio-Composite Suture Anchors remain the same as those cleared for the predicate PushLock, Tak, Corkscrew Suture Anchors (K061863) except for the exclusion of the hip indications. The Bio-Composite Suture Anchors are not indicated to be used for the capsular and acetabular labral repair.
The Bio-composite Suture Anchors have been developed using different biodegradable materials such as Poly (L-Lactide) (PLLA) and (PLDLA) Poly L-co-D-L-Lactide and ceramic material TriCalcium Phosphate (TCP). The biodearadable materials of the Bio-Composite Suture Anchors are currently used in the manufacturing of numerous Arthrex marketed bioabsorbable devices. The composite materials used in the construction of the Bio-Composite Suture Anchors have a long history of implantable use in the medical field and have been shown to be biocompatible.
The Arthrex Bio-Composite Suture Anchor family is substantially equivalent to the predicate device Suture Anchor family from K061863, where basic features and intended uses are the same. Any design differences between the Arthrex Bio-Composite Suture Anchors and the original Family of Suture Anchors are considered minor and do not raise questions concerning safety and effectiveness.
Based on the information submitted, Arthrex has determined that the Bio-Composite Suture Anchor Family is substantially equivalent to the cleared Suture Anchor Family, K061863.
Refer to Table 9-7 for a comparison of the similarities and differences between the cleared Arthrex Suture Anchors (K061863) and the new devices, the Arthrex Bio-Composite Suture Anchors.
2
| Similarities
and
Differences | Arthrex Bio-Composite
Suture Anchors
This "Special" Submission | Arthrex PushLok, Tak, and
Corkscrew Suture Anchors
CLEARED, (K061863) |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | MAI, HWC | HWC, MBI, JDR, MAI |
| 21 CFR | 888.3030
888.3040 | 888.3040
888.3030 |
| Design | Screw-In, push-In Anchors:
Full threaded, cannulated/ non-
cannulated, partially
cannulated, with or without
suture eyelet. | Screw-In, push-In Anchors:
Full threaded, cannulated/
non- cannulated, partially
cannulated, with or without
suture eyelet. |
| Material | PLLA/TCP or PLDLA/TCP | PLLA, PLDLA, PEEK,
Titanium |
| Intended Use | Identical | Identical |
| Indications for Use | Identical except for the
exclusion of the hip indications. | Fixation of suture (soft
tissue) to bone in the
shoulder, foot/ankle,
hip, knee, hand/wrist,
elbow, and pelvis. For suture or tissue
fixation in the foot,
ankle, hip, hand, wrist,
elbow, shoulder, and in
select maxillofacial
applications where size
is appropriate. |
| Diameter | 3-5.5 mm | 2.4 - 6.5 mm |
| Length | 14-14.7 mm | 5- 18.5 mm |
| Threaded | Yes | Yes |
| Sutures | Insert molded and supplied
with, or recommended Suture.
Polyblend | Insert molded and supplied
with, or recommended
Suture.
Polyblend |
| Packaging | Identical | Identical |
| Sterile | Yes | Yes |
| Shelf Life | 2 years | 2 years- PLLA, PLDLA
5 years- PEEK and Ti |
| Single Use | Yes | Yes |
- A comparison of Cleared Suture Anchor Family and the new Bio-Table 3-1 Composite Suture Anchor Family.
3
Pge 4 of 4
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features an eagle with its wings spread, clutching a caduceus in its talons. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 9 2007
Arthrex, Inc. % Ms. Mariela Cabarcas Regulatory Affairs Associate 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K071177 Trade/Device Name: Arthrex Bio-Composite Suture Anchors Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC, MBI, JDR, MAI Dated: June 5, 2007 Received: June 6, 2007
Dear Ms. Cabarcas:
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 indications 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, Drug, 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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device 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.
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 of 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 listing (21 CFR Part 807); labeling (21 CFR Part 801); 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 1000-1050.
5
Page 2 - Ms. Mariela Cabarcas
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or 240-276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours Mark N. Melkerson
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
pye 'fs
Arthrex SPECIAL 510(K); Arthrex Bio-Composite Suture Anchors
Indications for Use Form assala
Indications for Use
510(k) Number: Device Name:
Ko71177
Arthrex Bio-Composite Corkscrew
The Arthrex Bio-Composite Corkscrew is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and pelvis in, but not limited to, the following procedures:
| Shoulder: | Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction. |
|---|---|
| Foot/Ankle: | Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy. |
| Knee: | Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis. |
| Hand/Wrist: | Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction. |
| Elbow: | Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial collateral Ligament Reconstruction, Lateral Epicondylitis Repair. |
| Pelvis: | Bladder Neck Suspension for female urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency. |
Prescription Use _ X_AND/OR Over-The-Counter Use
Use No
(Per 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
currence of CDRH, Office of Device Evaluation (ODE) PAGE 1 of 3
(Division Sign-Off Division of General, Restorative, and Neurological Devices
510(k) Number Page 4 of 26 | L071177
7
page 2/3
Arthrex SPECIAL 510(K): Arthrex Bio-Composite Sulture Anchors
Indications for Use
510(k) Number: Device Name:
| The A. A. A. S. C. C. C. C. C. CANADIC - CARDER & C. CLANDING & A CLAIM CLASS OF CLASS OF CLASS OF CLASS OF CLASS OF CLASS OF CLASS OF CLASS OF CLASS OF CLASS OF CLASS OF CLA | Company of the comments of the comments of | ||
|---|---|---|---|
| ------------------------------------------------------------------------------------------------------------------------ | P | ||
| THE A L A Children A C A B . A . C . C . C | |||
| MORE LEELERS | |||
| ------- | AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA | ||
| 1 | |||
| 1 | Company of Canadian Compress of Actually Company Company Comprehensive Company of T. |
The Arthrex Bio-Composite PushLock™ is intended for fixation of suture (soft tissue) to bone in the shoulder, footlankle, knee, hand/wrist, elbow, and pelvis in the following procedures:
| Shoulder: | Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction. |
|---|---|
| Foot/Ankle: | Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy. |
| Knee: | Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis. |
| Hand/Wrist: | Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction. |
| Elbow: | Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair. |
| Pelvis: | Bladder Neck Suspension for female urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency. |
Prescription Use X AND/OR Over-The-Counter Use No
(Per 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) PAGE 2 of 3
8
Page 3 of 3
Co SPECIAL 510(K): Arthrex Bio-Composite Suture Anchors
Indications for Use
510(k) Number: Device Name:
Ko71177
Arthrex Bio-Composite Tak
The Arthrex Bio-Composite Tak™ is intended to be used for suture or tissue fixation in the foot, ankle, knee, hand, wrist, shoulder, elbow, and in select maxillofacial applications. Specific indications are listed below and are size appropriate per patient needs:
- Stabilization and fixation of oral cranio-maxillofacial skeletal bone, Skull: mandible and maxillofacial bones, Lateral Canthoplasty, Repair of Nasal Vestibular Stenosis, Brow Lift, Temporomandibular Joint (TMJ) reconstruction, Soft tissue attachment to the parietal temporal ridge, frontal, zygoma, and perioorbital bones of the skull. Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Elbow. Reconstruction. Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Shoulder: Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction. Scapholunate Ligament Reconstruction, Carpal Ligament Hand/Wrist: Reconstruction, Repair/Reconstruction of Collateral Ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP
- Foot/Ankle. Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus Reconstruction, Digital Tendon Transfers, Mid-foot reconstruction,
joints for all digits, Digital Tendon Transfers.
- Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis.
- Pelvis: Bladder Neck Suspension for female urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency.
Prescription Use X AND/OR Over-The-Counter Use N ?
(Per 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)
PAGE 3 of 3