Device Classification Name |
intervertebral fusion device with integrated fixation, lumbar
|
510(k) Number |
K120557 |
Device Name |
SOLITARIE PEEK ANTERIOR SPINAL SYSTEM-TO BE CALLED COLITAIRE 35 |
Applicant |
BIOMET SPINE & BONE HEALING TECHNOLOGIES |
100 INTERPACE PARKWAY |
PARSIPPANY,
NJ
07054
|
|
Applicant Contact |
MARGARET F CROWE |
Correspondent |
BIOMET SPINE & BONE HEALING TECHNOLOGIES |
100 INTERPACE PARKWAY |
PARSIPPANY,
NJ
07054
|
|
Correspondent Contact |
MARGARET F CROWE |
Regulation Number | 888.3080
|
Classification Product Code |
|
Date Received | 02/24/2012 |
Decision Date | 03/19/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|