KXA · Class II · 21 CFR 888.3400

FDA Product Code KXA: Prosthesis, Hip, Femoral, Resurfacing

Leading manufacturers include Wrightmedicaltechnologyinc, Biomet, Inc. and Biocore9, LLC.

23
Total
23
Cleared
93d
Avg days
1977
Since

FDA 510(k) Cleared Prosthesis, Hip, Femoral, Resurfacing Devices (Product Code KXA)

23 devices
1–23 of 23
Cleared Jan 19, 2021
Biocore9 Femoral Head Resurfacing Component
K201219
Biocore9, LLC
Orthopedic · 258d
Cleared Dec 12, 2008
CONSERVE PRESSFIT FEMORAL COMPONENT
K082673
Wrightmedicaltechnologyinc
Orthopedic · 88d
Cleared Jun 29, 2007
RECAP HA PRESS-FIT FEMORAL RESURFACING HEAD
K071053
Biomet, Inc.
Orthopedic · 77d
Cleared Dec 01, 2006
CONSERVE FEMORAL RESURFACING COMPONENT
K062960
Wrightmedicaltechnologyinc
Orthopedic · 63d
Cleared Dec 04, 2003
DEPUY ASR RESURFACING FEMORAL HEADS
K032659
DePuy Orthopaedics, Inc.
Orthopedic · 98d
Cleared Dec 03, 1998
NELSON RESURFACING HEAD
K983452
Biomet, Inc.
Orthopedic · 64d

About Product Code KXA - Regulatory Context