Absorbable Metallic Bone Fixation Fastener
The Absorbable Metallic Bone Fixation Fastener is an orthopedic implant, such as a bone screw, pin, or Kirschner wire, composed of absorbable metal or metal alloys designed to provide rigid bone fixation for osteosynthesis, with the device fully absorbing after osteosynthesis is achieved. It is classified as FDA Class 2, requiring 510(k) clearance, regulated under 21 CFR 888.3041 within the Orthopedic medical specialty. The product code is QJD, and the device carries both an implant flag and a life-sustaining flag, reflecting its critical role in structural bone repair and tissue support.
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Basic Information
- Product Code
- QJD
- Device Class
- FDA class 2
- Regulation Number
- 888.3041
- Medical Specialty
- Orthopedic
- Review Panel
- OR
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| DEN220030 | RemeOs Screw LAG Solid | Mar 29, 2023 | Unknown | Bioretec, Ltd. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.