OQH — Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented Class II
FDA product code OQH covers "Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented", a Class II medical device regulated under 21 CFR 888.3350. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants.
Classification Details
- Product Code
- OQH
- Device Class
- Class II
- Regulation Number
- 888.3350
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
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.