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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name appliance, fixation, spinal intervertebral body
510(k) Number K073708
Device Name FIXED, VARIABLE & CORPECTOMY CERVICAL PLATE SYSTEM
Applicant
PRECISION SURGERY LTD.
8202 SHERMAN ROAD
CHESTERLAND,  OH  44026 -2141
Applicant Contact KAREN E WARDEN
Correspondent
PRECISION SURGERY LTD.
8202 SHERMAN ROAD
CHESTERLAND,  OH  44026 -2141
Correspondent Contact KAREN E WARDEN
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received12/31/2007
Decision Date 06/03/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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