Device Classification Name |
Thoracolumbosacral Pedicle Screw System
|
510(k) Number |
K133188 |
Device Name |
MANTIS & MANTIS REDUX SPINAL SYSTEM, RADIUS SPINAL SYSTEM, TRIO & TRIO+ SPINAL FIXATION SYSTEMS, AND TRIO TRAUMA SPINAL |
Applicant |
STRYKER SPINE |
2 PEARL COURT |
ALLENDALE,
NJ
07401
|
|
Applicant Contact |
SORAYA KING |
Correspondent |
STRYKER SPINE |
2 PEARL COURT |
ALLENDALE,
NJ
07401
|
|
Correspondent Contact |
SORAYA KING |
Regulation Number | 888.3070
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 10/17/2013 |
Decision Date | 12/17/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|