CALLOS PROMODEL BONE VOID FILLER, SKAFFOLD MP (MACRO POROUS) BONE VOID FILLER


Device Classification Name

filler, bone void, calcium compound

510(k) Number K112383
Device Name CALLOS PROMODEL BONE VOID FILLER, SKAFFOLD MP (MACRO POROUS) BONE VOID FILLER
Applicant
SKELETAL KINETICS, LLC
10201 bubb rd.
cupertino, 
CA 
95014 -4167

Applicant Contact christine kuo
Correspondent
SKELETAL KINETICS, LLC
10201 bubb rd.
cupertino, 
CA 
95014 -4167

Correspodent Contact christine kuo
Regulation Number 888.3045
Classification Product Code
MQV  
Date Received 08/18/2011
Decision Date 02/07/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No