Device Classification Name |
orthosis, spondylolisthesis spinal fixation
|
510(k) Number |
K053623 |
Device Name |
NFIX FUSION SYSTEM |
Applicant |
N-SPINE, INC. |
P.O. BOX 560 |
STILLWATER,
MN
55082
|
|
Applicant Contact |
ELAINE DUNCAN |
Correspondent |
N-SPINE, INC. |
P.O. BOX 560 |
STILLWATER,
MN
55082
|
|
Correspondent Contact |
ELAINE DUNCAN |
Regulation Number | 888.3070
|
Classification Product Code |
|
Date Received | 12/28/2005 |
Decision Date | 07/12/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|