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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, facet screw spinal device
510(k) Number K102438
Device Name PRIMALOK FACET FIXATION SYSTEM
Applicant
OSTEOMED L.P.
8202 SHERMAN ROAD
CHESTERLAND,  OH  44026
Applicant Contact KAREN E WARDEN
Correspondent
OSTEOMED L.P.
8202 SHERMAN ROAD
CHESTERLAND,  OH  44026
Correspondent Contact KAREN E WARDEN
Classification Product Code
MRW  
Date Received08/26/2010
Decision Date 09/30/2010
Decision Substantially Equivalent (SESE)
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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