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