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

Filler, Bone Void, Calcium Compound

SKELETAL KINETICS, LLC

The following data is part of a premarket notification filed by Skeletal Kinetics, Llc with the FDA for Callos Promodel Bone Void Filler, Skaffold Mp (macro Porous) Bone Void Filler.

Pre-market Notification Details

Device IDK112383
510k NumberK112383
Device Name:CALLOS PROMODEL BONE VOID FILLER, SKAFFOLD MP (MACRO POROUS) BONE VOID FILLER
ClassificationFiller, Bone Void, Calcium Compound
Applicant SKELETAL KINETICS, LLC 10201 BUBB RD. Cupertino,  CA  95014 -4167
ContactChristine Kuo
CorrespondentChristine Kuo
SKELETAL KINETICS, LLC 10201 BUBB RD. Cupertino,  CA  95014 -4167
Product CodeMQV  
CFR Regulation Number888.3045 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-08-18
Decision Date2012-02-07
Summary:summary

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