SYNTHES STERNAL FIXATION SYSTEM
Device Facts
| Record ID | K010943 |
|---|---|
| Device Name | SYNTHES STERNAL FIXATION SYSTEM |
| Applicant | Synthes (Usa) |
| Product Code | JDQ · Orthopedic |
| Decision Date | Jun 27, 2001 |
| Decision | SESE |
| Submission Type | Abbreviated |
| Regulation | 21 CFR 888.3010 |
| Device Class | Class 2 |
Regulatory Classification
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.
