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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Methyl Methacrylate For Cranioplasty
510(k) Number K072601
Device Name OSTEOSYMBIONICS PATIENT SPECIFIC CRANIAL IMPLANT
Applicant
OSTEOSYMBIONICS, LLC
1768 EAST 25TH STREET
CLEVELAND,  OH  44114
Applicant Contact CYNTHIA M BROGAN
Correspondent
OSTEOSYMBIONICS, LLC
1768 EAST 25TH STREET
CLEVELAND,  OH  44114
Correspondent Contact CYNTHIA M BROGAN
Regulation Number882.5300
Classification Product Code
GXP  
Subsequent Product Code
GXN  
Date Received09/14/2007
Decision Date 12/10/2007
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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