Device Classification Name |
Orthosis, Spondylolisthesis Spinal Fixation
|
510(k) Number |
K123164 |
Device Name |
SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEM |
Applicant |
SPINEFRONTIER, INC. |
500 CUMMINGS CENTER |
SUITE 3500 |
BEVERLY,
MA
01915
|
|
Applicant Contact |
FREDY H VARELA |
Correspondent |
SPINEFRONTIER, INC. |
500 CUMMINGS CENTER |
SUITE 3500 |
BEVERLY,
MA
01915
|
|
Correspondent Contact |
FREDY H VARELA |
Regulation Number | 888.3070
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 10/09/2012 |
Decision Date | 02/15/2013 |
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
|
|
|