Device Classification Name |
intervertebral fusion device with bone graft, cervical
|
510(k) Number |
K103655 |
Device Name |
OCTANE-C INTERBODY FUSION DEVICE SYSTEM |
Applicant |
EXACTECH, INC. |
2320 N.W. 66TH CT. |
GAINESVILLE,
FL
32653
|
|
Applicant Contact |
PATRICK HUGHES |
Correspondent |
EXACTECH, INC. |
2320 N.W. 66TH CT. |
GAINESVILLE,
FL
32653
|
|
Correspondent Contact |
PATRICK HUGHES |
Regulation Number | 888.3080
|
Classification Product Code |
|
Date Received | 12/15/2010 |
Decision Date | 06/30/2011 |
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
|
|
|