SKELETAL DYNAMICS GEMINUS VOLAR DISTAL RADIUS PLATE MODEL STANDARD 3 HOLE RIGHT, STANDARD 3 HOLE LEFT, SKELETAL DYNAMICS


Device Classification Name

plate, fixation, bone

510(k) Number K111620
Device Name SKELETAL DYNAMICS GEMINUS VOLAR DISTAL RADIUS PLATE MODEL STANDARD 3 HOLE RIGHT, STANDARD 3 HOLE LEFT, SKELETAL DYNAMICS
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

Correspodent Contact ana m escagedo
Regulation Number 888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received 06/10/2011
Decision Date 08/23/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No