Device Classification Name |
plate, cranioplasty, preformed, non-alterable
|
510(k) Number |
K180064 |
Device Name |
OsteoFab Patient Specific Cranial Device |
Applicant |
Oxford Performance Materials, Inc. |
30 South Satellite Road |
South Windsor,
CT
06074
|
|
Applicant Contact |
M. Beth Pashko |
Correspondent |
Oxford Performance Materials, Inc. |
30 South Satellite Road |
South Windsor,
CT
06074
|
|
Correspondent Contact |
M. Beth Pashko |
Regulation Number | 882.5330
|
Classification Product Code |
|
Date Received | 01/09/2018 |
Decision Date | 07/27/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|