(102 days)
Not Found
No
The 510(k) summary 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 or ML.
Yes
The device is described as an anterior cervical plate system to be used as an adjunct to fusion for the treatment of various disc and spinal conditions, indicating a therapeutic purpose.
No
The device, FortiBridge™ Anterior Cervical Plate System, is an implant used for fixation and fusion in the cervical spine. Its purpose is therapeutic (to treat various spinal conditions), not to diagnose a condition.
No
The device description explicitly states that the system consists of implants and instruments, which are physical hardware components (anterior cervical plate and screw system).
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 FortiBridge™ Anterior Cervical Plate System is an implantable device (a plate and screws) used for surgical fixation of the cervical spine. It is physically placed within the body.
- Intended Use: The intended use describes a surgical procedure to stabilize the spine, not a diagnostic test performed on a sample outside the body.
Therefore, based on the provided information, the FortiBridge™ Anterior Cervical Plate System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The FortiBridge™ Anterior Cervical Plate System is intended for anterior screw fixation of the cervical spine (C2 to T1). The system is to be used as an adjunct to fusion for the treatment of 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), tumors, spinal stenosis, deformity (i.e., kyphosis or scoliosis), pseudarthrosis or failed previous fusion.
Product codes
KWO
Device Description
The FortiBridge™ System consists of implants and instruments for implantation. It is an anterior cervical plate and screw system which includes fixed and variable screws having standard, self-drilling or self-tapping tips, and one- through four-level plates. The implants are available in a variety of sizes to accommodate the individual anatomic and clinical circumstances of each patient.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine (C2 to T1)
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 10, 2015
Nanovis Spine LLC % Karen Warden, Ph.D. President Backroads Consulting, Incorporated P.O. Box 566 Chesterland. Ohio 44026
Re: K143706
Trade/Device Name: FortiBridge™ Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWO Dated: March 16, 2015 Received: March 17, 2015
Dear Dr. Warden:
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
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Page 2 - Karen Warden, Ph.D.
(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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please 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.htm 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement on last page.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
FortiBridge™ Anterior Cervical Plate System
Indications for Use (Describe)
The FortiBridge™ Anterior Cervical Plate System is intended for anterior screw fixation of the cervical spine (C2 to T1). The system is to be used as an adjunct to fision for the treatment of 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), tumors, spinal stenosis, deformity (i.e., kyphosis or scoliosis), 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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(k) Summary
| Date: | 26 December 2014 |
|---|---|
| Sponsor: | Nanovis Spine, LLC |
| 5865 East State Rd. 14 | |
| Columbia City, Indiana 46725 USA | |
| (877) 907-6266 | |
| (260) 625-3834 | |
| Contact Person: | Matthew Hedrick, CEO & Chief Operating Officer |
| Trade Name: | FortiBridge™ Anterior Cervical Plate System |
| Common Name: | Anterior cervical plate system |
| Device Classification | Class II |
| Classification Name: | Spinal intervertebral body fixation orthosis |
| Regulation: | 21 CFR 888.3060 |
| Device Product | |
| Codes: | KWQ |
| Device Description: | The FortiBridge™ System consists of implants and instruments for |
| implantation. It is an anterior cervical plate and screw system which | |
| includes fixed and variable screws having standard, self-drilling or | |
| self-tapping tips, and one- through four-level plates. The implants are | |
| available in a variety of sizes to accommodate the individual | |
| anatomic and clinical circumstances of each patient. | |
| Intended Use: | The FortiBridge™ Anterior Cervical Plate System is intended for |
| anterior screw fixation of the cervical spine (C2 to T1). The system is | |
| to be used as an adjunct to fusion for the treatment of 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), | |
| tumors, spinal stenosis, deformity (i.e., kyphosis, lordosis or | |
| scoliosis), pseudarthrosis or failed previous fusion. | |
| Materials: | FortiBridge™ implants are manufactured from titanium alloy as |
| described by ASTM F136. | |
| Predicate Devices: | Primary: ATLANTIS® Anterior Cervical Plate System (Medtronic |
| Sofamor Danek, USA Inc. – К130640) | |
| Additional: | |
| Spider Cervical Plating System (X-Spine Systems Inc. – К052292) | |
| Cervical Spine Locking Plate (CSLP) (Synthes Spine – K945700) | |
| Performance Data: | |
| Technological | |
| Characteristics: | FortiBridge™ possesses the same technological characteristics as |
| the predicate devices. These include: | |
| performance (as described above), basic design (plate and screw system), implant grade materials (titanium alloy), and sizes (dimensions are within the range(s) offered by the predicates). Therefore the fundamental scientific technology of the FortiBridge™ | |
| devices is the same as previously cleared devices. | |
| Conclusion: | The FortiBridge™ Anterior Cervical Plate System possesses the |
| same intended use and technological characteristics as the predicate | |
| devices. Therefore FortiBridge™ Anterior Cervical Plate System is | |
| substantially equivalent for its intended use. |
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