FDA product code QJD: Absorbable Metallic Bone Fixation Fastener
QJD is the FDA product code for absorbable metallic bone fixation fastener. It is a Class II device, regulated under 21 CFR 888.3041 and reviewed by the Orthopedic panel. Devices under QJD reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Absorbable Metallic Bone Fixation Fastener |
| Device class | Class II |
| Regulation | 21 CFR 888.3041 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
| Life-sustaining or supporting | Yes |
Recalls for QJD devices
openFDA lists no recalls for product code QJD.
Frequently asked questions
What is FDA product code QJD?
QJD is the FDA product code for absorbable metallic bone fixation fastener. It is a Class II device, regulated under 21 CFR 888.3041 and reviewed by the Orthopedic panel.
What device class is QJD?
Class II, regulation 21 CFR 888.3041. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code QJD
- Run a recall and safety report across every QJD manufacturer
- Watch product code QJD for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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