Device Classification Name |
Appliance, Fixation, Spinal Intervertebral Body
|
510(k) Number |
K112861 |
Device Name |
SINTEA PLUSTEK ANTERIOR CERVICAL PLATE SYSTEM |
Applicant |
SINTEA PLUSTEK, LLC |
407 LINCOLN ROAD, SUITE 10L |
MIAMI BEACH,
FL
33139
|
|
Applicant Contact |
DANIELLE WERNIKOWSKI |
Correspondent |
SINTEA PLUSTEK, LLC |
407 LINCOLN ROAD, SUITE 10L |
MIAMI BEACH,
FL
33139
|
|
Correspondent Contact |
DANIELLE WERNIKOWSKI |
Regulation Number | 888.3060
|
Classification Product Code |
|
Date Received | 09/30/2011 |
Decision Date | 02/24/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|