Product code OCG

Device name

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

Medical specialty

Orthopedic

Device class

3

Regulation number

888.3410

Review panel

OR

Implant

Y

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

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.

Source

FDA openFDA device classification dataset