MINI VARIABLE SYSTEM


Device Classification Name

plate, fixation, bone

510(k) Number K111041
Device Name MINI VARIABLE SYSTEM
Applicant
ORTHOHELIX SURGICAL DESIGNS, INC.
1065 medina road
suite 500
medina, 
OH 
44256

Applicant Contact derek lewis
Correspondent
ORTHOHELIX SURGICAL DESIGNS, INC.
1065 medina road
suite 500
medina, 
OH 
44256

Correspodent Contact derek lewis
Regulation Number 888.3030
Classification Product Code
HRS  
Date Received 04/14/2011
Decision Date 06/06/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No