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Instrument Makar, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
28
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K002600LITWIN CRUICATE ANCHORNovember 15, 2000
K980999ST LEGER CEMENTED SEMI-CONSTRAINED TOTAL KNEE IMPLANTNovember 6, 1998
K963396BIOSPHERE SUTURE ANCHORMay 6, 1997
K964364DISPOSABLE APRONFebruary 25, 1997
K955835FLUID BARRIER BOOT KNEE & ANKLE-HIGHNovember 19, 1996
K960555BIOASBSORBABLE MINI-SCREW SUTURE ANCHORJuly 9, 1996
K943249BIOABSORBABLE INTERFERENCE SCREWJuly 31, 1995
K942828MAKAR FULL AND HALF FACE SHIELDFebruary 23, 1995
K944062LAPRASCOPIC GRASPERFebruary 23, 1995
K930980INSTRUMENT MAKAR PERFIX INTERFERENCE BONE SCREWFebruary 10, 1994
K923841BONE SCREWSOctober 27, 1993
K912021MAKAR MINI CANNULATED CANCELLOUS SCREWSNovember 22, 1991
K910723BIODEGRADABLE SURGICAL STAPLEMarch 12, 1991
K905365INSTRUMENT MAKAR GRAVITY ASSIST SYSTEMFebruary 6, 1991
K902854GRAVITY ASSISTAugust 29, 1990
K890972HOOK TIP SURGICAL CAUTERY ELECTRODE BLADEMarch 22, 1989
K890973STRAIGHT PADDLE SURGICAL CAUTERY ELECTRODE BLADEMarch 22, 1989
K885311MENISCUS MENDER II LOOPFebruary 9, 1989
K882407BOW & ARROW DRILL GUIDESeptember 6, 1988
K853597INSTRUMENT MAKAR DISPOSALBE LOOPSeptember 23, 1985