Device Classification Name |
orthosis, spondylolisthesis spinal fixation
|
510(k) Number |
K061813 |
Device Name |
MANTIS SPINAL SYSTEM |
Applicant |
STRYKER SPINE |
2 PEARL COURT |
ALLENDALE,
NJ
07401
|
|
Applicant Contact |
SIMONA VOIC |
Correspondent |
STRYKER SPINE |
2 PEARL COURT |
ALLENDALE,
NJ
07401
|
|
Correspondent Contact |
SIMONA VOIC |
Regulation Number | 888.3070
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 06/27/2006 |
Decision Date | 09/19/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|