Device Classification Name |
Intervertebral Fusion Device With Bone Graft, Lumbar
|
510(k) Number |
K120991 |
Device Name |
TRANS1 INTERBODY FUSION SYSTEM |
Applicant |
TRANS1 INCORPORATED |
301 Government Center Dr Suite 100 |
WILMINGTON,
NC
28403
|
|
Applicant Contact |
CHERYL L WAGONER |
Correspondent |
TRANS1 INCORPORATED |
301 Government Center Dr Suite 100 |
WILMINGTON,
NC
28403
|
|
Correspondent Contact |
CHERYL L WAGONER |
Regulation Number | 888.3080
|
Classification Product Code |
|
Date Received | 04/02/2012 |
Decision Date | 08/23/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|