QJD
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Absorbable Metallic Bone Fixation Fastener
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3041
- Medical specialty
- Orthopedic
- Flags
- Implant · Life-sustaining
- FDA definition
- 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| RemeOs™ Screw LAG Solid (DEN220030) | Bioretec, Ltd. | 2023-03-29 |
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Every clearance here is in the API, with alerts when new ones post.