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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K943160
Device Name INTERFERENCE SCREW
Applicant
Applied Osteo Systems, Inc.
1243 Alpine Rd.
Suite 221
Walnut Creek,  CA  94596
Applicant Contact SCOTT HUNTLEY
Correspondent
Applied Osteo Systems, Inc.
1243 Alpine Rd.
Suite 221
Walnut Creek,  CA  94596
Correspondent Contact SCOTT HUNTLEY
Regulation Number888.3040
Classification Product Code
HWC  
Date Received07/01/1994
Decision Date 09/30/1994
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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