NDD · Cerclage, Fixation, Metallic
Orthopedic · 21 CFR 888.3010 · Class 2
Overview
| Product Code | NDD |
|---|---|
| Device Name | Cerclage, Fixation, Metallic |
| Regulation | 21 CFR 888.3010 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
| Implant | Yes |
Identification
A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.
Classification Rationale
Class II.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K003618 | WHITESIDE BIOMECHANICS LOW PROFILE STAINLESS STEEL CABLE SYSTEM, MODEL BIO-1-1014 | Whiteside Biomechanics, Inc. | May 23, 2001 | SESE |
Top Applicants
- Whiteside Biomechanics, Inc. — 1 clearance
