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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K923841
Device Name BONE SCREWS
Applicant
Instrument Makar, Inc.
C/O Abood,Abood & Rheaume,P.C.
117 E. Allegan St.
Lansing,  MI  48933
Applicant Contact JEROME F ABOOD
Correspondent
Instrument Makar, Inc.
C/O Abood,Abood & Rheaume,P.C.
117 E. Allegan St.
Lansing,  MI  48933
Correspondent Contact JEROME F ABOOD
Regulation Number888.3040
Classification Product Code
HWC  
Date Received07/31/1992
Decision Date 10/27/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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