Device Classification Name |
Plate, Fixation, Bone
|
510(k) Number |
K122310 |
Device Name |
GEMINUS FOSSA SPECIFIC PLATE SYSTEM |
Applicant |
SKELETAL DYNAMICS, LLC |
8905 SW 87 AVENUE, SUITE 201 |
MIAMI,
FL
33176
|
|
Applicant Contact |
ANA M ESCAGEDO |
Correspondent |
SKELETAL DYNAMICS, LLC |
8905 SW 87 AVENUE, SUITE 201 |
MIAMI,
FL
33176
|
|
Correspondent Contact |
ANA M ESCAGEDO |
Regulation Number | 888.3030
|
Classification Product Code |
|
Date Received | 08/01/2012 |
Decision Date | 01/18/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|