21 CFR 888.3010 — Cerclage, Fixation
Orthopedic (OR) · Part 888 Subpart D—Prosthetic Devices · § 888.3010
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| JDQ | Cerclage, Fixation | 2 | 129 | Implant |
| NDD | Cerclage, Fixation, Metallic | 2 | 1 | Implant |
| OWI | Bone Fixation Cerclage, Sublaminar | 2 | 36 | Implant |
