FDA product code QPQ: Shoulder Spacer For Massive Irreparable Rotator Cuff Tear, Resorbable, Inflatable, Non-Fixed
QPQ is the FDA product code for shoulder spacer for massive irreparable rotator cuff tear, resorbable, inflatable, non-fixed. It is a Class II device, regulated under 21 CFR 888.3630 and reviewed by the Orthopedic panel. Devices under QPQ reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
Definition
A resorbable shoulder spacer is intended to act as a temporary spacer, creating a physical barrier between tissues in the shoulder, for the treatment of massive irreparable rotator cuff tears.
Classification
| Field | Value |
|---|---|
| Device name | Shoulder Spacer For Massive Irreparable Rotator Cuff Tear, Resorbable, Inflatable, Non-Fixed |
| Device class | Class II |
| Regulation | 21 CFR 888.3630 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
Recalls for QPQ devices
openFDA lists no recalls for product code QPQ.
Frequently asked questions
What is FDA product code QPQ?
QPQ is the FDA product code for shoulder spacer for massive irreparable rotator cuff tear, resorbable, inflatable, non-fixed. It is a Class II device, regulated under 21 CFR 888.3630 and reviewed by the Orthopedic panel.
What device class is QPQ?
Class II, regulation 21 CFR 888.3630. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code QPQ
- Run a recall and safety report across every QPQ manufacturer
- Watch product code QPQ 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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