BICERA (TM) RESORBABLE BONE SUBSTITUTE


Device Classification Name

filler, bone void, calcium compound

510(k) Number K110949
Device Name BICERA (TM) RESORBABLE BONE SUBSTITUTE
Applicant
WILTROM CORPORATION LIMITED
no. 221, sec 1, chung hsing rd
chutung township, hsinchu, 

TW

31053

Applicant Contact yung-chih wu
Correspondent
WILTROM CORPORATION LIMITED
no. 221, sec 1, chung hsing rd
chutung township, hsinchu, 

TW

31053

Correspodent Contact yung-chih wu
Regulation Number 888.3045
Classification Product Code
MQV  
Date Received 04/04/2011
Decision Date 09/18/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No