QJD · Absorbable Metallic Bone Fixation Fastener
Orthopedic · 21 CFR 888.3041 · Class 2
Overview
| Product Code | QJD |
|---|---|
| Device Name | Absorbable Metallic Bone Fixation Fastener |
| Regulation | 21 CFR 888.3041 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
| Implant | Yes |
| Life-Sustaining | Yes |
Identification
An absorbable metallic bone fixation fastener is an implant, such as a bone screw, pin, or Kirschner wire, composed of one or more absorbable metal or metal alloys and intended to provide rigid bone fixation suitable for osteosynthesis. The device is designed to fully absorb after steosynthesis is achieved.
Cleared Devices (1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| DEN220030 | RemeOs Screw LAG Solid | Bioretec, Ltd. | Mar 29, 2023 | DENG |
Top Applicants
- Bioretec, Ltd. — 1 clearance
