BONESAVE BONE VOID FILLER

Device Classification Name

filler, bone void, calcium compound

510(k) Number K033258
Device Name BONESAVE BONE VOID FILLER
Applicant
HOWMEDICA OSTEONICS
59 route 17
allendale, 
NJ 
07401 -1677

Applicant Contact lorraine montemurro
Correspondent
HOWMEDICA OSTEONICS
59 route 17
allendale, 
NJ 
07401 -1677

Correspodent Contact lorraine montemurro
Regulation Number 888.3045
Classification Product Code
MQV  
Date Received 10/09/2003
Decision Date 03/09/2004
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No