OSTEOFAB PATIENT SPECIFIC CRANIAL DEVICE


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

Correspodent Contact leigh ayres
Regulation Number 882.5330
Classification Product Code
GXN  
Date Received 06/20/2012
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