Device Classification Name |
Rod, Fixation, Intramedullary And Accessories
|
510(k) Number |
K123401 |
Device Name |
GAMMA3 AND T2 RECON TARGETING DEVICES |
Applicant |
Stryker Trauma AG |
325 Corporate Drive |
Mahwah,
NJ
07430
|
|
Applicant Contact |
ESTELA CELI |
Correspondent |
Stryker Trauma AG |
325 Corporate Drive |
Mahwah,
NJ
07430
|
|
Correspondent Contact |
ESTELA CELI |
Regulation Number | 888.3020
|
Classification Product Code |
|
Date Received | 11/05/2012 |
Decision Date | 01/23/2013 |
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
|
|
|