OCG · Class III — High Risk (PMA approval required, life-sustaining) · Orthopedic · 21 CFR 888.3410
Classification
FDA Product Code
OCG
Device class
Class III — High Risk (PMA approval required, life-sustaining)
Regulation
21 CFR 888.3410
Review panel
OR
Medical specialty
Orthopedic
Submission type
2
GMP exempt
N
Life sustaining
N
Implant
Y
Third-party review
N
Definition
Call for PMAs to be filed by 1/3/05 per 69 FR 59134 on 10/4/04 - Intended to replace the articulating surfaces of the hip while preserving the femoral head and neck and indicated for osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis of the femoral head.