Device Classification Name |
Intervertebral Fusion Device With Integrated Fixation, Lumbar
|
510(k) Number |
K093629 |
Device Name |
SOLITAIRE AND SOLITAIRE PEEK ANTERIOR SPINAL SYSTEM |
Applicant |
BIOMET SPINE |
100 INTERPACE PARKWAY |
PARSIPPANY,
NJ
07054
|
|
Applicant Contact |
VIVIAN KELLY |
Correspondent |
BIOMET SPINE |
100 INTERPACE PARKWAY |
PARSIPPANY,
NJ
07054
|
|
Correspondent Contact |
VIVIAN KELLY |
Regulation Number | 888.3080
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 11/23/2009 |
Decision Date | 03/09/2010 |
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
|
|
|