KWH · Class II · 21 CFR 888.3720

FDA Product Code KWH: Prosthesis, Toe, Constrained, Polymer

Leading manufacturers include In2bones USA, LLC, Fusion Orthopedics, LLC and Brm Extremities.

21
Total
21
Cleared
116d
Avg days
1978
Since

FDA 510(k) Cleared Prosthesis, Toe, Constrained, Polymer Devices (Product Code KWH)

21 devices
1–21 of 21
Cleared Feb 13, 2020
NewPrim System
K191966
Brm Extremities
Orthopedic · 205d
Cleared Oct 21, 2019
Fusion Silastic System
K190136
Fusion Orthopedics, LLC
Orthopedic · 265d
Cleared Feb 23, 2018
RTS Lesser MTP Implant System
K173491
In2bones USA, LLC
Orthopedic · 102d
Cleared Jan 24, 1983
ZIMMER GREAT TOE
K823405
Zimmer, Inc.
Orthopedic · 70d

About Product Code KWH - Regulatory Context