Device Classification Name |
appliance, fixation, spinal interlaminal
|
510(k) Number |
K122378 |
Device Name |
NEXTGEN ALTIUS OCT SYSTEM |
Applicant |
BIOMET SPINE (AKA EBI, LLC) |
100 INTERPACE PARKWAY |
PARSIPPANY,
NJ
07054
|
|
Applicant Contact |
VIVIAN KELLY |
Correspondent |
BIOMET SPINE (AKA EBI, LLC) |
100 INTERPACE PARKWAY |
PARSIPPANY,
NJ
07054
|
|
Correspondent Contact |
VIVIAN KELLY |
Regulation Number | 888.3050
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 08/06/2012 |
Decision Date | 09/20/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|