Product code KMC— Orthopedic
APR REVISION HIP PROSTHESIS, FEMORAL COMPONENT
- Classification name
- Prosthesis, Hip, Semi-Constrained, Composite/Metal
- Device class
- Class 2
- Regulation
- 21 CFR 888.3340
- Advisory panel
- Orthopedic
- Total cleared
- 3
- First cleared
- Most recent
Market context for product code KMC
FDA has cleared devices under product code KMC between 1985 and 1994, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 1994
- 1985
Top applicants under product code KMC
Recent clearances under product code KMC
Data sourced from openFDA. This site is unofficial and independent of the FDA.