Device Classification Name |
Spinal Vertebral Body Replacement Device
|
510(k) Number |
K032812 |
Device Name |
ENDOSKELETON TA VERTEBRAL BODY REPLACEMENT |
Applicant |
ORTHOVITA, INC. |
45 GREAT VALLEY PKWY. |
MALVERN,
PA
19355
|
|
Applicant Contact |
DAVID J MCILHENNY |
Correspondent |
ORTHOVITA, INC. |
45 GREAT VALLEY PKWY. |
MALVERN,
PA
19355
|
|
Correspondent Contact |
DAVID J MCILHENNY |
Regulation Number | 888.3060
|
Classification Product Code |
|
Date Received | 09/09/2003 |
Decision Date | 12/08/2003 |
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
|
|
|