(61 days)
Not Found
No
The document describes a mechanical implant system for spinal fusion and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as an "adjunct to fusion" and provides "stabilization" for various medical conditions, indicating its role in treating or managing health conditions.
No
The device, the Zavation Cervical Plate System, is an implant used for stabilization during cervical spine fusion as an adjunct to fusion. It is a treatment device, not a diagnostic one.
No
The device description explicitly states it consists of "self-tapping/self-drilling screws and plates," which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The Zavation Cervical Plate System is described as a system of screws and plates intended for surgical implantation in the cervical spine.
- Intended Use: The intended use is for anterior screw fixation of the cervical spine as an adjunct to fusion, addressing various spinal conditions. This is a surgical procedure, not a diagnostic test performed on specimens outside the body.
The device is a surgical implant used to stabilize the spine, not a tool for diagnosing conditions by analyzing biological samples.
N/A
Intended Use / Indications for Use
The Zavation Cervical Plate System is intended for anterior screw fixation of the cervical spine (C2-C7) as an adjunct to fusion. These implants have been designed to provide stabilization for the following indications: degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), tumor, pseudarthrosis or failed previous fusion.
Product codes (comma separated list FDA assigned to the subject device)
KWQ
Device Description
The Zavation Cervical Plate System consists of self-tapping/self-drilling screws and plates. Screws are available in a variety of diameter and length combinations. Plates are available in a variety of lengths.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine (C2-C7)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Biomechanical testing was not repeated, as the basis for this submission is the addition of sterile packaged options for the predicate device.
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
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.
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Zavation Medical Products LLC Mr. Matt Jones Design Engineer 220 Lakeland Parkway Flowood, Mississippi 39232
Re: K181244
Trade/Device Name: Zavation Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: May 4, 2018 Received: May 10, 2018
Dear Mr. Jones:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 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); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820);
July 10, 2018
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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/1/Picture/6 description: The image shows the name "Brent Showalter -S" in a large, sans-serif font. The text is black and stands out against a white background. The letters are evenly spaced, and the overall impression is clean and professional. The "-S" at the end is slightly smaller than the rest of the name.
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K181244
Device Name Zavation Cervical Plate System
Indications for Use (Describe)
The Zavation Cervical Plate System is intended for anterior screw fixation of the cervical spine (C2-C7) as an adjunct to fusion. These implants have been designed to provide stabilization for the following indications: degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), tumor, pseudarthrosis or failed previous fusion.
Type of Use (Select one or both, as applicable) | |
---|---|
☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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K181244 - 510K Summary
Date: | May 4, 2018 |
---|---|
Submitter: | Zavation Medical Products LLC |
220 Lakeland Pkwy | |
Flowood, MS 39232 | |
Phone: 601-919-1119 | |
Fax: 800-447-1302 | |
Contact Person: | Matt Jones |
Type of 510(k) submission: | Traditional |
Trade name: | Zavation Cervical Plate System |
Common name: | Anterior Cervical Plate |
Classification regulation: | 888.3060 |
Device classification: | Class II |
Classification Panel: | Orthopedic |
Product code: | KWQ |
Basis for submission: | Addition of sterile packaged implants and instruments. |
Prior Submissions: | K112533 and K130030. Both received Substantial |
Equivalence determinations |
Device Description:
The Zavation Cervical Plate System consists of self-tapping/self-drilling screws and plates. Screws are available in a variety of diameter and length combinations. Plates are available in a variety of lengths.
Intended Use:
The Zavation Cervical Plate System is intended for anterior screw fixation of the cervical spine (C2-C7) as an adjunct to fusion. These implants have been designed to provide stabilization for the treatment of the following indications: degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), tumor, pseudarthrosis or failed previous fusion.
Materials:
The Zavation Cervical Plate System implants are manufactured from titanium alloy (Ti-6Al-4V) as described by ASTM F136.
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Primary Predicate Device:
K112533 Zavation Cervical Plate System [Zavation]
Additional Predicate Device:
K103491 SKYLINE Anterior Cervical Plate System [DePuy]
Technological Characteristics:
The Zavation Cervical Plate System possesses the same technological characteristics as the predicates. These include: basic design (plate designed fixation system having various screw diameters and lengths), material (titanium alloy), sizes (variety of plate and screw sizes), and intended use (as described above).
Performance Data:
Biomechanical testing was not repeated, as the basis for this submission is the addition of sterile packaged options for the predicate device.
Conclusion:
The Zavation Cervical Plate System is substantially equivalent to the devices referenced above.