Device Classification Name |
intervertebral fusion device with bone graft, lumbar
|
510(k) Number |
K121288 |
Device Name |
FUSE CAGE |
Applicant |
ADVANCED MEDICAL TECHNOLOGIES AG |
KASTELER STRASSE 11 |
NONNWEILER-BRAUNSHAUSEN,
DE
66620
|
|
Applicant Contact |
J.D. WEBB |
Correspondent |
ADVANCED MEDICAL TECHNOLOGIES AG |
KASTELER STRASSE 11 |
NONNWEILER-BRAUNSHAUSEN,
DE
66620
|
|
Correspondent Contact |
J.D. WEBB |
Regulation Number | 888.3080
|
Classification Product Code |
|
Date Received | 04/30/2012 |
Decision Date | 06/29/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|