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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Table, Operating-Room, Pneumatic
510(k) Number K953961
Device Name OSTEONICS INSIGHT KNEE POSITIONING & ALIGNMENT SYSTEM
Applicant
Osteonics Corp.
59 Rte. 17
Allendale,  NJ  07401
Applicant Contact TERRY JAROSZ
Correspondent
Osteonics Corp.
59 Rte. 17
Allendale,  NJ  07401
Correspondent Contact TERRY JAROSZ
Regulation Number878.4960
Classification Product Code
FWW  
Subsequent Product Codes
HWT   KKX   LXH  
Date Received08/22/1995
Decision Date 11/29/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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