Device Classification Name |
thoracolumbosacral pedicle screw system
|
510(k) Number |
K100737 |
Device Name |
MODIFICATION TO: TRIO+SPINAL FIXATION SYSTEM |
Applicant |
STRYKER SPINE |
2 PEARL COURT |
ALLENDALE,
NJ
07401
|
|
Applicant Contact |
CURTIS TRUESDALE |
Correspondent |
STRYKER SPINE |
2 PEARL COURT |
ALLENDALE,
NJ
07401
|
|
Correspondent Contact |
CURTIS TRUESDALE |
Regulation Number | 888.3070
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 03/15/2010 |
Decision Date | 04/12/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|