Device Classification Name |
Posterior Metal/Polymer Spinal System, Fusion
|
510(k) Number |
K061774 |
Device Name |
NFIX II PEDICLE SCREW SYSTEM |
Applicant |
N SPINE, INC. |
13221 MARICOTTE PLACE |
SAN DIEGO,
CA
92130
|
|
Applicant Contact |
R. STEPHEN REITZLER |
Correspondent |
N SPINE, INC. |
13221 MARICOTTE PLACE |
SAN DIEGO,
CA
92130
|
|
Correspondent Contact |
R. STEPHEN REITZLER |
Regulation Number | 888.3070
|
Classification Product Code |
|
Date Received | 06/23/2006 |
Decision Date | 12/13/2006 |
Decision |
SE - With Limitations
(SESU) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
Yes
|
Recalls |
CDRH Recalls
|
|
|