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OQHClass II

Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented

21 CFR 888.3350 / Orthopedic
FDA source (opens on fda.gov)

OQH is the FDA product code for Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented, a class II device type, regulated under 21 CFR 888.3350. FDA's definition for this code reads: "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...". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
OQH
Device name
Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented
FDA 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.
Regulation
21 CFR 888.3350
Device class
Class II
Review panel
Orthopedic
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 42 companies shown, in name order