Protek, Inc. - FDA 510(k) Cleared Devices
25
Total
20
Cleared
0
Denied
25 devices
Cleared
Aug 09, 1989
ARC-2F ACETABULAR CUP
Orthopedic
79d
Cleared
Jul 25, 1989
P.S.A. FEMORAL HIP PROSTHESIS
Orthopedic
54d
Cleared
Jul 19, 1989
FEMORAL HEADS/MODULAR & FIXED W/ TITAN NITRIDE SUR
Orthopedic
112d
Cleared
May 26, 1989
RESUBMITTED CLW ACETABULAR CUP W/SULMESH
Orthopedic
261d
Cleared
May 10, 1989
VARIOUS FEMORAL HIP PROSTHESES W/SELF LOCK CERAMIC
Orthopedic
162d
Cleared
Feb 27, 1989
MODIFIED O.E.C. UNIV. SELF-ALIGNING ACETA. COMP.
Orthopedic
97d
Cleared
Feb 08, 1989
NEW JERSEY FEMORAL HIP PROSTHESIS FOR CEMENT APPLI
Orthopedic
85d
Cleared
Feb 08, 1989
M.E.M. ACETABULAR CUP W/SULMESH FOR CEMENT APPLI.
Orthopedic
33d
Cleared
Dec 29, 1988
MODIFIED NEW JERSEY ACETABULAR COMP. & BONE SCREWS
Orthopedic
37d
Cleared
Oct 20, 1988
SAMUELSON SCREWLOC CUP
Orthopedic
114d
Cleared
Jan 27, 1988
SLS-88 TOTAL HIP SYSTEM, ACETABULAR CUP
Orthopedic
111d
Cleared
Oct 28, 1987
C.L.E. ACETABULAR CUP
Orthopedic
239d
Cleared
Oct 28, 1987
FREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEE
Orthopedic
64d
Cleared
Oct 01, 1987
SAMUELSON ACETABULAR CUP
Orthopedic
62d
Cleared
Sep 14, 1987
SCHUSTER ACETABULAR CUP FOR CEMENT/CEMENTLESS FIX.
Orthopedic
194d
Cleared
Sep 14, 1987
CLX ACETABULAR CUP (WAGNER) FOR CEMENTLESS FIXAT.
Orthopedic
194d
Cleared
Jul 23, 1987
M.W.P. WRIST PROSTHESIS
Orthopedic
29d
Cleared
Jul 01, 1987
WAGNER REVISIONAL FEMORAL HIP PROSTHESIS
Orthopedic
86d
Cleared
Feb 11, 1987
MODIFIED PROTASUL 100 (TI-6A1-7NB) ALLOY
Orthopedic
278d
Cleared
Aug 07, 1986
C.S.M. HIP
Orthopedic
16d
Cleared
Feb 18, 1986
FREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEE REP
Orthopedic
165d
Cleared
Nov 19, 1985
MULLER SELF LOCKING TOTAL HIP
Orthopedic
71d
Cleared
Sep 24, 1985
MUELLER CURVED STEM HEMI-PROSTHESIS
Orthopedic
21d
Cleared
Sep 06, 1985
DAY STAPLE
Orthopedic
32d
Cleared
Sep 04, 1985
FREEMAN UNI-COMPARTMENTAL KNEE
Orthopedic
30d