SYNTHES (USA) RETROGRADE/ANTEGRADE FEMORAL NAIL SYSTEM

Device Classification Name

rod, fixation, intramedullary and accessories

510(k) Number K033618
Device Name SYNTHES (USA) RETROGRADE/ANTEGRADE FEMORAL NAIL SYSTEM
Applicant
SYNTHES (USA)
1690 russell rd.
paoli, 
PA 
19301

Applicant Contact bonnie smith
Correspondent
SYNTHES (USA)
1690 russell rd.
paoli, 
PA 
19301

Correspodent Contact bonnie smith
Regulation Number 888.3020
Classification Product Code
HSB  
Subsequent Product Code
HWC  
Date Received 11/18/2003
Decision Date 02/05/2004
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