OVZ · Pin, Fixation, Resorbable, Hard Tissue
Orthopedic · 21 CFR 888.3040 · Class 2
Overview
| Product Code | OVZ |
|---|---|
| Device Name | Pin, Fixation, Resorbable, Hard Tissue |
| Regulation | 21 CFR 888.3040 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
| Implant | Yes |
Identification
A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.
Classification Rationale
Class II.
Cleared Devices (3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K140625 | ORTHOSORB LS | Biomet, Inc. | Apr 18, 2014 | SESE |
| K111077 | ORTHOSORB RESORBABLE PINS | DePuy Orthopaedics, Inc. | Jul 12, 2011 | SESE |
| K901456 | ORTHOSORB(R) ABSORBABLE PIN | Johnson & Johnson International | Aug 15, 1990 | SESE |
Top Applicants
- Johnson & Johnson International — 1 clearance
- DePuy Orthopaedics, Inc. — 1 clearance
- Biomet, Inc. — 1 clearance
