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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
510(k) Number K952543
Device Name GRAFTOLOGER PGH & ACL RECONSTRUCTION INSTRUMENT SET
Applicant
Neoligaments, Ltd.
28-30 Blenheim Ter.
Leeds,  GB LS2-9HD
Applicant Contact JRJ ROWLAND
Correspondent
Neoligaments, Ltd.
28-30 Blenheim Ter.
Leeds,  GB LS2-9HD
Correspondent Contact JRJ ROWLAND
Regulation Number878.4820
Classification Product Code
HWE  
Subsequent Product Codes
FZX   HWA   HWB  
Date Received05/18/1995
Decision Date 06/22/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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