Device Classification Name |
Prosthesis, Rib Replacement
|
510(k) Number |
K142587 |
Device Name |
Vertical Expandable Prosthetic Titanium Rib |
Applicant |
Depuy Synthes Spine, Inc. |
325 Paramount Drive |
Raynham,
MA
02767
|
|
Applicant Contact |
Catherine Kilshaw |
Correspondent |
Depuy Synthes Spine, Inc. |
325 Paramount Drive |
Raynham,
MA
02767
|
|
Correspondent Contact |
Catherine Kilshaw |
Regulation Number | 888.3070
|
Classification Product Code |
|
Date Received | 09/15/2014 |
Decision Date | 11/18/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|