FDA.reportPublic FDA data

SKELETAL KINETICS, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30038904763003890476SKELETAL KINETICS, LLC1N2020-04-253885 Arapaho Road Addison TX US 75001

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
613331037617032K162864OsteoVation ImpactGXP2017-01-13
613331942168880K120354BETA-TCP GRANULESMQV2013-03-21
613331812863686K112383CALLOS PROMODEL BONE VOID FILLER, SKAFFOLD MP (MACRO POROUS) BONE VOID FILLERMQV2012-02-07
613331479716920K100986CALLOS BONE VOID FILLER, SKAFFOLD NEXT GENERATION BONE VOID FILLER, OSTEO VATIONMQV2010-07-20
613331693934785K051784OSTEOVATION CMF BONE VOID FILLERGXP2005-07-20
613331709416079K051123CALLOS IMPACT AND INJECT BONE VOID FILLERMQV2005-06-03
613331005227350K042072CALLOS CMF BONE VOID FILLERGXP2004-09-16
613331018843715
613331298565817

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MQV42013-03-21
GXP32017-01-13

PMN#