Device Classification Name |
Intervertebral Fusion Device With Bone Graft, Lumbar
|
510(k) Number |
K123461 |
Device Name |
STAXX(R) IB SYSTEM |
Applicant |
SPINE WAVE, INC. |
THREE ENTERPRISE DR. |
SUITE 210 |
SHELTON,
CT
06484
|
|
Applicant Contact |
ROAIDA RIZKALLAH |
Correspondent |
SPINE WAVE, INC. |
THREE ENTERPRISE DR. |
SUITE 210 |
SHELTON,
CT
06484
|
|
Correspondent Contact |
ROAIDA RIZKALLAH |
Regulation Number | 888.3080
|
Classification Product Code |
|
Date Received | 11/09/2012 |
Decision Date | 04/11/2013 |
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
|
|
|