Device Classification Name |
appliance, fixation, spinal intervertebral body
|
510(k) Number |
K143576 |
Device Name |
Exactech Ambassador |
Applicant |
EXACTECH, INC. |
2320 NW 66TH COURT |
GAINESVILLE,
FL
32653
|
|
Applicant Contact |
DAWN DAVISSON |
Correspondent |
Empirical Testing Corp. |
4628 Northpark Drive |
Colorado Springs,
CO
80918
|
|
Correspondent Contact |
KENNETH C MAXWELL |
Regulation Number | 888.3060
|
Classification Product Code |
|
Date Received | 12/17/2014 |
Decision Date | 02/27/2015 |
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
|
|
|