PHQ · Anterior Staple As Supplemental Fixation For Fusion
Orthopedic · 21 CFR 888.3060 · Class 2
Overview
| Product Code | PHQ |
|---|---|
| Device Name | Anterior Staple As Supplemental Fixation For Fusion |
| Regulation | 21 CFR 888.3060 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
| Implant | Yes |
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.
Classification Rationale
Class II.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K200301 | UNiTi ACDF Implant System | Pressio, Inc. | Feb 3, 2021 | SESE |
| K133906 | C-JAWS CERVICAL COMPRESSIVE STAPLE | Medicrea International | Jul 24, 2014 | SESE |
Top Applicants
- Pressio, Inc. — 1 clearance
- Medicrea International — 1 clearance
