Device Classification Name |
thoracolumbosacral pedicle screw system
|
510(k) Number |
K133746 |
Device Name |
POLARIS SPINAL SYSTEM |
Applicant |
BIOMET SPINE (AKA EBI, LLC) |
399 JEFFERSON ROAD |
PARSIPPANY,
NJ
07054
|
|
Applicant Contact |
VIVIAN KELLY, MS, RAC |
Correspondent |
BIOMET SPINE (AKA EBI, LLC) |
399 JEFFERSON ROAD |
PARSIPPANY,
NJ
07054
|
|
Correspondent Contact |
VIVIAN KELLY, MS, RAC |
Regulation Number | 888.3070
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 12/09/2013 |
Decision Date | 03/12/2014 |
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
|
|
|