Device Classification Name |
Intervertebral Fusion Device With Integrated Fixation, Cervical
|
510(k) Number |
K120819 |
Device Name |
STALIF C |
Applicant |
CENTINEL SPINE, INC. |
900 AIRPORT RD, STE #3B |
WEST CHESTER,
PA
19380
|
|
Applicant Contact |
JOHN PARRY |
Correspondent |
CENTINEL SPINE, INC. |
900 AIRPORT RD, STE #3B |
WEST CHESTER,
PA
19380
|
|
Correspondent Contact |
JOHN PARRY |
Regulation Number | 888.3080
|
Classification Product Code |
|
Date Received | 03/19/2012 |
Decision Date | 08/31/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|