Device Classification Name |
orthosis, spondylolisthesis spinal fixation
|
510(k) Number |
K141376 |
Device Name |
INERTIA PEDICLE SCREW SYSTEM, HONOUR SPACER SYSTEM, FACET FIXX, STRUXXURE ANTERIOR CERVICAL PLATE AND SCREWS |
Applicant |
NEXXT SPINE LLC |
PO BOX 566 |
CHESTERLAND,
OH
44026
|
|
Applicant Contact |
KAREN E WARDEN |
Correspondent |
NEXXT SPINE LLC |
PO BOX 566 |
CHESTERLAND,
OH
44026
|
|
Correspondent Contact |
KAREN E WARDEN |
Regulation Number | 888.3070
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 05/27/2014 |
Decision Date | 06/26/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|