Medical Device Manufacturer · US , Indianapolis , IN

Protek, Inc.

25 submissions · 20 cleared · Since 1985
25
Total
20
Cleared
0
Denied

Protek, Inc. — FDA 510(k) Submissions

Protek, Inc. has submitted 25 FDA 510(k) premarket notifications since 1985, of which 20 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented, Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component), Prosthesis, Hip, Hemi-, Femoral, Metal, Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented, Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uhmwpe, Pegged, Cemented, Polymer/metal/polymer . Use the specialty filter in the sidebar to narrow results.

25 devices
1–25 of 25
ARC-2F ACETABULAR CUP
K893785 · LWJ Prosthesis, Hip,... · Orthopedic
Aug 1989 79d
P.S.A. FEMORAL HIP PROSTHESIS
K893959 · KWY Prosthesis, Hip, Hemi-,... · Orthopedic
Jul 1989 54d
FEMORAL HEADS/MODULAR & FIXED W/ TITAN NITRIDE SUR
K892059 · LZY Prosthesis, Hip, Hemi-,... · Orthopedic
Jul 1989 112d
RESUBMITTED CLW ACETABULAR CUP W/SULMESH
K883794 · LWJ Prosthesis, Hip,... · Orthopedic
May 1989 261d
VARIOUS FEMORAL HIP PROSTHESES W/SELF LOCK CERAMIC
K884952 · LZO Prosthesis, Hip,... · Orthopedic
May 1989 162d
MODIFIED O.E.C. UNIV. SELF-ALIGNING ACETA. COMP.
K884889 · KWL Prosthesis, Hip, Hemi-,... · Orthopedic
Feb 1989 97d
NEW JERSEY FEMORAL HIP PROSTHESIS FOR CEMENT APPLI
K884789 · KWL Prosthesis, Hip, Hemi-,... · Orthopedic
Feb 1989 85d
M.E.M. ACETABULAR CUP W/SULMESH FOR CEMENT APPLI.
K890054 · JDI Prosthesis, Hip,... · Orthopedic
Feb 1989 33d
MODIFIED NEW JERSEY ACETABULAR COMP. & BONE SCREWS
K884888 · JDI Prosthesis, Hip,... · Orthopedic
Dec 1988 37d
SAMUELSON SCREWLOC CUP
K882671 · KWA Prosthesis, Hip,... · Orthopedic
Oct 1988 114d
SLS-88 TOTAL HIP SYSTEM, ACETABULAR CUP
K874093 · JDI Prosthesis, Hip,... · Orthopedic
Jan 1988 111d
C.L.E. ACETABULAR CUP
K870922 · JDI Prosthesis, Hip,... · Orthopedic
Oct 1987 239d
FREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEE
K873429 · MBV Prosthesis, Knee,... · Orthopedic
Oct 1987 64d
SAMUELSON ACETABULAR CUP
K872985 · KWA Prosthesis, Hip,... · Orthopedic
Oct 1987 62d
SCHUSTER ACETABULAR CUP FOR CEMENT/CEMENTLESS FIX.
K870923 · KWA Prosthesis, Hip,... · Orthopedic
Sep 1987 194d
CLX ACETABULAR CUP (WAGNER) FOR CEMENTLESS FIXAT.
K870924 · KWA Prosthesis, Hip,... · Orthopedic
Sep 1987 194d
M.W.P. WRIST PROSTHESIS
K872502 · KWM Prosthesis, Wrist,... · Orthopedic
Jul 1987 29d
WAGNER REVISIONAL FEMORAL HIP PROSTHESIS
K871347 · JDI Prosthesis, Hip,... · Orthopedic
Jul 1987 86d
MODIFIED PROTASUL 100 (TI-6A1-7NB) ALLOY
K861988 · JDI Prosthesis, Hip,... · Orthopedic
Feb 1987 278d
C.S.M. HIP
K862752 · Orthopedic
Aug 1986 16d
FREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEE REP
K853730 · MBV Prosthesis, Knee,... · Orthopedic
Feb 1986 165d
MULLER SELF LOCKING TOTAL HIP
K853768 · JDI Prosthesis, Hip,... · Orthopedic
Nov 1985 71d
MUELLER CURVED STEM HEMI-PROSTHESIS
K853662 · KWL Prosthesis, Hip, Hemi-,... · Orthopedic
Sep 1985 21d
DAY STAPLE
K853267 · JDR Staple, Fixation, Bone · Orthopedic
Sep 1985 32d
FREEMAN UNI-COMPARTMENTAL KNEE
K853268 · HSX Prosthesis, Knee,... · Orthopedic
Sep 1985 30d
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