Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer
KXB is the FDA product code for Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer, a class III device type, regulated under 21 CFR 888.3410. FDA's definition for this code reads: "Pma to be filed by 1/3/05 (69 fr 59134 (10/4/04)) for any hip joint metal/polymer or ceramic/polymer semiconstrained resurfacing cemented prosthesis that was in commercial distribution before may 28, 1976, or that has, on or before january 3, 2005, been found to be substantially equivalent to a hip joint metal/polymer...". As of , FDA records hold no 510(k) clearances under this code and 3 recalls.
Classification record
- Product code
- KXB
- Device name
- Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer
- FDA definition
- Pma to be filed by 1/3/05 (69 fr 59134 (10/4/04)) for any hip joint metal/polymer or ceramic/polymer semiconstrained resurfacing cemented prosthesis that was in commercial distribution before may 28, 1976, or that has, on or before january 3, 2005, been found to be substantially equivalent to a hip joint metal/polymer or ceramic/polymer semiconstrained resurfacing cemented prosthesis that was in commercial distribution before may 28, 1976. Any other hip joint metal/polymer or ceramic/polymer semiconstrained resurfacing cemented prosthesis must have an approved pma or a declared completed pdp in effect before being placed in commercial distribution.
- 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
- 3
Companies listing this code with FDA
Companies whose registered establishments list this codeNo registered establishment in MDM’s records lists product code KXB.
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.