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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fastener, Fixation, Nondegradable, Soft Tissue
510(k) Number K002600
Device Name LITWIN CRUICATE ANCHOR
Applicant
Instrument Makar, Inc.
2950 E. Mt. Hope Rd.
Okemos,  MI  48864
Applicant Contact LANNY L JOHNSON
Correspondent
Instrument Makar, Inc.
2950 E. Mt. Hope Rd.
Okemos,  MI  48864
Correspondent Contact LANNY L JOHNSON
Regulation Number888.3040
Classification Product Code
MBI  
Subsequent Product Code
HWC  
Date Received08/21/2000
Decision Date 11/15/2000
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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