Protek, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
25
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K893785ARC-2F ACETABULAR CUPAugust 9, 1989
K893959P.S.A. FEMORAL HIP PROSTHESISJuly 25, 1989
K892059FEMORAL HEADS/MODULAR & FIXED W/ TITAN NITRIDE SURJuly 19, 1989
K883794RESUBMITTED CLW ACETABULAR CUP W/SULMESHMay 26, 1989
K884952VARIOUS FEMORAL HIP PROSTHESES W/SELF LOCK CERAMICMay 10, 1989
K884889MODIFIED O.E.C. UNIV. SELF-ALIGNING ACETA. COMP.February 27, 1989
K884789NEW JERSEY FEMORAL HIP PROSTHESIS FOR CEMENT APPLIFebruary 8, 1989
K890054M.E.M. ACETABULAR CUP W/SULMESH FOR CEMENT APPLI.February 8, 1989
K884888MODIFIED NEW JERSEY ACETABULAR COMP. & BONE SCREWSDecember 29, 1988
K882671SAMUELSON SCREWLOC CUPOctober 20, 1988
K874093SLS-88 TOTAL HIP SYSTEM, ACETABULAR CUPJanuary 27, 1988
K873429FREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEEOctober 28, 1987
K870922C.L.E. ACETABULAR CUPOctober 28, 1987
K872985SAMUELSON ACETABULAR CUPOctober 1, 1987
K870924CLX ACETABULAR CUP (WAGNER) FOR CEMENTLESS FIXAT.September 14, 1987
K870923SCHUSTER ACETABULAR CUP FOR CEMENT/CEMENTLESS FIX.September 14, 1987
K872502M.W.P. WRIST PROSTHESISJuly 23, 1987
K871347WAGNER REVISIONAL FEMORAL HIP PROSTHESISJuly 1, 1987
K861988MODIFIED PROTASUL 100 (TI-6A1-7NB) ALLOYFebruary 11, 1987
K862752C.S.M. HIPAugust 7, 1986