OQH · Class II — Moderate Risk (510(k) clearance required) · Orthopedic · 21 CFR 888.3350
Classification
FDA Product Code
OQH
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 888.3350
Review panel
OR
Medical specialty
Orthopedic
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
Y
Third-party review
N
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.