Concept, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
83
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K912640CONCEPT ENDOSTEAL FIXATION DEVICEMay 1, 1992
K912957CONCEPT MICROMILLOctober 4, 1991
K896648CONCEPT UNICOMPARTMENTAL KNEE SYSTEMJune 5, 1990
K894929STAPLE FIXATION SYSTEMAugust 30, 1989
K892376INTRAVISION(TM) ARTHROSCOPE SYSTEM (ADD'L APPLI.)August 1, 1989
K891109PANDA(R) NEEDLE CATHETER JEJUNOSTOMY TUBEMay 8, 1989
K881954CONCEPT POWER SYSTEMNovember 9, 1988
K884255CONCEPT CCT-5200, THERMAL THERAPY SYSTEMNovember 8, 1988
K882121C-FLO SUCTION TUBEJune 20, 1988
K880414TENDON HARVESTERMarch 25, 1988
K874676INTERFERENCE SCREWMarch 7, 1988
K880413PATELLAR TENDON GRAFT GUIDEMarch 4, 1988
K874515CONCEPT SUTURE NEEDLENovember 27, 1987
K874439SOFT TISSUE ANCHORING SET KITNovember 20, 1987
K872608HEWSON A.C.L. GUIDE SETSeptember 16, 1987
K873030CONCEPT ARTHROSCOPIC PORTAL RODSeptember 16, 1987
K873009CONCEPT SWITCHING STICKAugust 17, 1987
K872156CONCEPT SELF COMPRESSING CANNULATED SCREW SYSTEMJuly 21, 1987
K871037CANCELLOUS FIXATION SCREW & WASHER FOR USE W/SCREWMarch 25, 1987
K863396CONCEPT INTRAVISION ARTHROSCOPE SYSTEMSeptember 12, 1986