MODULAR FOOT SYSTEM


Device Classification Name

plate, fixation, bone

510(k) Number K073624
Device Name MODULAR FOOT SYSTEM
Applicant
ORTHOHELIX SURGICAL DESIGNS, INC.
1815 w. market st.
suite 205
akron, 
OH 
44313

Applicant Contact derek lewis
Correspondent
ORTHOHELIX SURGICAL DESIGNS, INC.
1815 w. market st.
suite 205
akron, 
OH 
44313

Correspodent Contact derek lewis
Regulation Number 888.3030
Classification Product Code
HRS  
Date Received 12/26/2007
Decision Date 03/20/2008
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