Device Classification Name |
orthosis, spondylolisthesis spinal fixation
|
510(k) Number |
K093670 |
Device Name |
MODIFICATION TO: OASYS SYSTEM |
Applicant |
STRYKER SPINE |
2 PEARL COURT |
ALLENDALE,
NJ
07401
|
|
Applicant Contact |
PAULINE SHAND |
Correspondent |
STRYKER SPINE |
2 PEARL COURT |
ALLENDALE,
NJ
07401
|
|
Correspondent Contact |
PAULINE SHAND |
Regulation Number | 888.3070
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 11/27/2009 |
Decision Date | 03/18/2010 |
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
|
|
|