Device Classification Name |
intervertebral fusion device with bone graft, lumbar
|
510(k) Number |
K122989 |
Device Name |
BIOMET LATERAL SPACER SYSTEM |
Applicant |
BIOMET SPINE (AKA EBI, LLC) |
100 INTERPACE PARKWAY |
PARSIPPANY,
NJ
07054
|
|
Applicant Contact |
MARGARET F CROWE |
Correspondent |
BIOMET SPINE (AKA EBI, LLC) |
100 INTERPACE PARKWAY |
PARSIPPANY,
NJ
07054
|
|
Correspondent Contact |
MARGARET F CROWE |
Regulation Number | 888.3080
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/26/2012 |
Decision Date | 10/24/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|