FLEXFUSION (TM) FIXATION IMPLANT


Device Classification Name

screw, fixation, bone

510(k) Number K110445
Device Name FLEXFUSION (TM) FIXATION IMPLANT
Applicant
NEXTREMITY SOLUTIONS, LLC
167 stone hill road
colts neck, 
NJ 
07722

Applicant Contact arthur a alfaro
Correspondent
NEXTREMITY SOLUTIONS, LLC
167 stone hill road
colts neck, 
NJ 
07722

Correspodent Contact arthur a alfaro
Regulation Number 888.3040
Classification Product Code
HWC  
Date Received 02/16/2011
Decision Date 03/17/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No