JDN · Implant, Fixation Device, Spinal
Orthopedic · 21 CFR 888.3060 · Class 2
Overview
| Product Code | JDN |
|---|---|
| Device Name | Implant, Fixation Device, Spinal |
| 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.
Cleared Devices (6)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K954856 | CANNULATED FEMORAL NAIL | Synthes (Usa) | Mar 8, 1996 | SESE |
| K897141 | SLOT STAPLES AND ADAPTOR FOR ZIELKE SPINAL FIXATIO | Stuart | Jun 21, 1990 | SN |
| K894184 | BIEDERMANN MOTECH UNIVERSAL SPINAL SYSTEM | Biedermann Motech GmbH | Apr 25, 1990 | SN |
| K873977 | NEW C-D SYSTEM FOR SPINAL SURGERY | Sofamor Co. | Dec 7, 1987 | SN |
| K872715 | UNIVERSAL INSTRUMENTATION(CD) FOR SPINAL SURGERY | Roseburg SA | Dec 7, 1987 | SN |
| K760649 | TOTAL SPINAL CORRECTION | Depuy, Inc. | Oct 5, 1976 | SESE |
Top Applicants
- Synthes (Usa) — 1 clearance
- Stuart — 1 clearance
- Sofamor Co. — 1 clearance
- Roseburg SA — 1 clearance
- Depuy, Inc. — 1 clearance
