PRO FIXATION SYSTEM


Device Classification Name

screw, fixation, bone

510(k) Number K110538
Device Name PRO FIXATION SYSTEM
Applicant
SYNOVIS ORTHOPEDIC & WOUNDCARE
6 jenner, suite 150
irvine, 
CA 
92618

Applicant Contact amy boucly
Correspondent
SYNOVIS ORTHOPEDIC & WOUNDCARE
6 jenner, suite 150
irvine, 
CA 
92618

Correspodent Contact amy boucly
Regulation Number 888.3040
Classification Product Code
HWC  
Subsequent Product Code
MBI  
Date Received 02/25/2011
Decision Date 07/12/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No