POGO SCREW


Device Classification Name

screw, fixation, bone

510(k) Number K080649
Device Name POGO SCREW
Applicant
FXDEVICES
one south ocean blvd.
boca raton, 
FL 
33432

Applicant Contact rich lipschutz
Correspondent
FXDEVICES
one south ocean blvd.
boca raton, 
FL 
33432

Correspodent Contact rich lipschutz
Regulation Number 888.3040
Classification Product Code
HWC  
Date Received 03/07/2008
Decision Date 11/25/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No