NORIAN DRILLABLE


Device Classification Name

calcium salt bone void filler, drillable, non-screw augmentation

510(k) Number K073303
Device Name NORIAN DRILLABLE
Applicant
SYNTHES (USA)
1230 wilson drive
west chester, 
PA 
19380

Applicant Contact jeffrey l dow
Correspondent
SYNTHES (USA)
1230 wilson drive
west chester, 
PA 
19380

Correspodent Contact jeffrey l dow
Regulation Number 888.3045
Classification Product Code
OIS  
Subsequent Product Code
MQV  
Date Received 11/23/2007
Decision Date 07/02/2008
Decision

se – with limitations

(SESU)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No