Device Classification Name |
orthosis, spondylolisthesis spinal fixation
|
510(k) Number |
K120832 |
Device Name |
FORTEX PEDICLE SCREW SYSTEM |
Applicant |
X-SPINE SYSTEMS, INC |
452 Alexandersville Rd |
Miamisburg,
OH
45342
|
|
Applicant Contact |
DAVID KIRSCHMAN |
Correspondent |
X-SPINE SYSTEMS, INC |
452 Alexandersville Rd |
Miamisburg,
OH
45342
|
|
Correspondent Contact |
DAVID KIRSCHMAN |
Regulation Number | 888.3070
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/19/2012 |
Decision Date | 10/23/2012 |
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
|
|
|