Device Classification Name |
Intervertebral Fusion Device With Bone Graft, Cervical
|
510(k) Number |
K120517 |
Device Name |
DEPUY PULSE CERVICAL CAGE SYSTEM |
Applicant |
MEDOS INTERNATIONAL SARL |
325 PARAMOUNT DR |
RAYNHAM,
MA
02767
|
|
Applicant Contact |
EUGENE BANG |
Correspondent |
MEDOS INTERNATIONAL SARL |
325 PARAMOUNT DR |
RAYNHAM,
MA
02767
|
|
Correspondent Contact |
EUGENE BANG |
Regulation Number | 888.3080
|
Classification Product Code |
|
Date Received | 02/21/2012 |
Decision Date | 04/26/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|