Device Classification Name |
Intervertebral Fusion Device With Bone Graft, Lumbar
|
510(k) Number |
K141217 |
Device Name |
ACCULIF TL AND PL CAGE |
Applicant |
STRYKER CORPORATION |
2 PEARL COURT |
ALLENDALE,
NJ
07401
|
|
Applicant Contact |
KRISTEN MEANY |
Correspondent |
STRYKER CORPORATION |
2 PEARL COURT |
ALLENDALE,
NJ
07401
|
|
Correspondent Contact |
KRISTEN MEANY |
Regulation Number | 888.3080
|
Classification Product Code |
|
Date Received | 05/12/2014 |
Decision Date | 07/16/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|