OSTEO IC FEMORAL AND TIBIAL NAILS IN TITANIUM ALLOY


Device Classification Name

rod, fixation, intramedullary and accessories

510(k) Number K992063
Device Name OSTEO IC FEMORAL AND TIBIAL NAILS IN TITANIUM ALLOY
Applicant
HOWMEDICA OSTEONICS CORP.
59 route 17 south
allendale, 
NJ 
07401 -1677

Applicant Contact marybeth naughton
Correspondent
HOWMEDICA OSTEONICS CORP.
59 route 17 south
allendale, 
NJ 
07401 -1677

Correspodent Contact marybeth naughton
Regulation Number 888.3020
Classification Product Code
HSB  
Date Received 06/18/1999
Decision Date 09/03/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No