FDA product code OQH: Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented
OQH is the FDA product code for hip, semi-constrained, cemented, metal/polymer + additive, cemented. It is a Class II device, regulated under 21 CFR 888.3350 and reviewed by the Orthopedic panel. Devices under OQH reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis. 3. Correction of functional deformity. 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed. Cemented and uncemented use.
Classification
| Field | Value |
|---|---|
| Device name | Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented |
| Device class | Class II |
| Regulation | 21 CFR 888.3350 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
Recalls for OQH devices
openFDA lists no recalls for product code OQH.
Frequently asked questions
What is FDA product code OQH?
OQH is the FDA product code for hip, semi-constrained, cemented, metal/polymer + additive, cemented. It is a Class II device, regulated under 21 CFR 888.3350 and reviewed by the Orthopedic panel.
What device class is OQH?
Class II, regulation 21 CFR 888.3350. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code OQH
- Run a recall and safety report across every OQH manufacturer
- Watch product code OQH 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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