Device Classification Name |
intervertebral fusion device with bone graft, lumbar
|
510(k) Number |
K101085 |
Device Name |
SPINESMITH CYNCH SPINAL SYSTEM |
Applicant |
SPINE SMITH PARTNERS L.P. |
5300 NORTH LAMAR BLVD #107 |
AUSTIN,
TX
78751
|
|
Applicant Contact |
LAURA LEBOEUF |
Correspondent |
SPINE SMITH PARTNERS L.P. |
5300 NORTH LAMAR BLVD #107 |
AUSTIN,
TX
78751
|
|
Correspondent Contact |
LAURA LEBOEUF |
Regulation Number | 888.3080
|
Classification Product Code |
|
Date Received | 04/19/2010 |
Decision Date | 07/01/2010 |
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
|
|
|