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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 K914362
Device Name TOP CERVICAL SPINE PLATES & TITANIUM BONE SCREWS
Applicant
Acorn Group, Inc.
47 Quail Ct.
Suite 301
Walnut Creek,  CA  94596
Applicant Contact JAMES P.STOUT
Correspondent
Acorn Group, Inc.
47 Quail Ct.
Suite 301
Walnut Creek,  CA  94596
Correspondent Contact JAMES P.STOUT
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received10/01/1991
Decision Date 04/29/1992
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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