NORIAN XR CALCIUM PHOSPHATE BONE VOID FILLER


Device Classification Name

filler, bone void, calcium compound

510(k) Number K023862
Device Name NORIAN XR CALCIUM PHOSPHATE BONE VOID FILLER
Original Applicant
SYNTHES (USA)
1690 russell rd.
paoli, 
PA 
19301

Original Contact vikki m hoffman
Regulation Number 888.3045
Classification Product Code
MQV  
Date Received 11/20/2002
Decision Date 12/19/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

General & Plastic Surgery

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No