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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Cranioplasty, Preformed, Non-Alterable
510(k) Number K121818
Device Name OSTEOFAB PATIENT SPECIFIC CRANIAL DEVICE
Applicant
OXFORD PERFORMANCE MATERIALS
30 S SATELLITE ROAD
SOUTH WINDSOR,  CT  06074
Applicant Contact LEIGH AYRES
Correspondent
OXFORD PERFORMANCE MATERIALS
30 S SATELLITE ROAD
SOUTH WINDSOR,  CT  06074
Correspondent Contact LEIGH AYRES
Regulation Number882.5330
Classification Product Code
GXN  
Date Received06/20/2012
Decision Date 02/07/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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