Device Classification Name |
Intervertebral Fusion Device With Bone Graft, Cervical
|
510(k) Number |
K121178 |
Device Name |
TRANSCORP ACIF SYSTEM |
Applicant |
TRANSCORP, INC. |
1000 100TH ST. SW, SUITE F |
BYRON CENTER,
MI
49315
|
|
Applicant Contact |
ANDREW RODENHOUSE |
Correspondent |
TRANSCORP, INC. |
1000 100TH ST. SW, SUITE F |
BYRON CENTER,
MI
49315
|
|
Correspondent Contact |
ANDREW RODENHOUSE |
Regulation Number | 888.3080
|
Classification Product Code |
|
Date Received | 04/18/2012 |
Decision Date | 07/05/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|