Device Classification Name |
Intervertebral Fusion Device With Bone Graft, Lumbar
|
510(k) Number |
K120966 |
Device Name |
DEPUY PULSE LUMBAR CAGE SYSTEM |
Applicant |
MEDOS INTERNATIONAL SARL |
325 Paramount Drive |
Raynham,
MA
02767
|
|
Applicant Contact |
ROBIN DINARDO |
Correspondent |
MEDOS INTERNATIONAL SARL |
325 Paramount Drive |
Raynham,
MA
02767
|
|
Correspondent Contact |
ROBIN DINARDO |
Regulation Number | 888.3080
|
Classification Product Code |
|
Date Received | 03/30/2012 |
Decision Date | 07/03/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|