QJD — Absorbable Metallic Bone Fixation Fastener Class II
FDA product code QJD covers "Absorbable Metallic Bone Fixation Fastener", a Class II medical device regulated under 21 CFR 888.3041. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- QJD
- Device Class
- Class II
- Regulation Number
- 888.3041
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN220030 | bioretec | RemeOs Screw LAG Solid | March 29, 2023 |