FDA Product Code KWH: Prosthesis, Toe, Constrained, Polymer
Leading manufacturers include Nexa Orthopedics, Inc., Osteomed Corp. and In2bones USA, LLC.
21
Total
21
Cleared
116d
Avg days
1978
Since
FDA 510(k) Cleared Prosthesis, Toe, Constrained, Polymer Devices (Product Code KWH)
21 devices
Cleared
Feb 13, 2020
NewPrim System
Brm Extremities
Orthopedic
205d
Cleared
Oct 21, 2019
Fusion Silastic System
Fusion Orthopedics, LLC
Orthopedic
265d
Cleared
Feb 23, 2018
RTS Lesser MTP Implant System
In2bones USA, LLC
Orthopedic
102d
Cleared
Sep 08, 2016
RTS Flexible 1 MPJ Implant w/Grommets
In2bones USA, LLC
Orthopedic
266d
Cleared
Jan 17, 2003
LESSER METATARSAL PHALANGEAL JOINT IMPLANT
Nexa Orthopedics, Inc.
Orthopedic
88d
Cleared
Nov 26, 2002
INTERPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEM
Osteomed Corp.
Orthopedic
88d
Cleared
Nov 25, 2002
METATARSOPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEM
Osteomed Corp.
Orthopedic
87d
Cleared
Nov 13, 2002
MODIFICATION TO CLASSIC GREAT TOE IMPLANT
Nexa Orthopedics, Inc.
Orthopedic
21d
Cleared
Oct 04, 2002
CLASSIC GREAT TOE IMPLANT
Nexa Orthopedics, Inc.
Orthopedic
17d
Cleared
Jan 07, 2000
ASCENT KNEE SYSTEM
Biomet Manufacturing, Inc.
Orthopedic
16d
Cleared
Jun 30, 1998
FUTURA BIOMEDICAL FLEXIBLE GREAT TOE IMPLANT
Nexa Orthopedics, Inc.
Orthopedic
89d
Cleared
Jul 06, 1995
PROFIX CONFORMING PLUS TIBIAL INSERT
Smith & Nephew Richards, Inc.
Orthopedic
196d
Cleared
Jan 24, 1983
ZIMMER GREAT TOE
Zimmer, Inc.
Orthopedic
70d
Cleared
Jun 09, 1980
SILASTIC HAMMERTOE IMPLANT (SWANSON-WELL
Dow Corning Corp. Healthcare Industries Materials
Orthopedic
32d
Cleared
Feb 06, 1978
IMPLANT, HINGE TOE, FLEX.
Dow Corning Corp. Healthcare Industries Materials
Orthopedic
13d