510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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OCGClass III

Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer, Uncemented

21 CFR 888.3410 / Orthopedic
FDA source (opens on fda.gov)

OCG is the FDA product code for Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer, Uncemented, a class III device type, regulated under 21 CFR 888.3410. FDA's definition for this code reads: "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". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
OCG
Device name
Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer, Uncemented
FDA 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.
Regulation
21 CFR 888.3410
Device class
Class III
Review panel
Orthopedic
Submission type
PMA
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

No registered establishment in MDM’s records lists product code OCG.