ClearanceBrief
Company ยท US

Skeletal Kinetics, Llc

FDA 510(k) clearances and medical device recalls filed under this name, 2003 to 2017. Name variants (Inc, Corp, punctuation) are merged.

10510(k) clearances (0 in 12 months)
49recalls (0 in 12 months)
49recalls that name a 510(k)

Product codes

CodeDeviceRecords
MQVFiller, Bone Void, Calcium Compound30
GXPMethyl Methacrylate For Cranioplasty28
MTJWax, Bone1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Jan 13, 2017K162864OsteoVation Impact
Skeletal Kinetics, LLC
GXP
Aug 4, 2014K132211SKAFFOLD NMX BONE VOID FILLER
Skeletal Kinetics, LLC
MQV
Mar 21, 2013K120354BETA-TCP GRANULES
Skeletal Kinetics, LLC
MQV
Feb 7, 2012K112383CALLOS PROMODEL BONE VOID FILLER, SKAFFOLD MP (MACRO POROUS) BONE VOID FILLER
Skeletal Kinetics, LLC
MQV
Oct 25, 2011K111538SKAFFOLD CIS
Skeletal Kinetics, LLC
MTJ
Jul 20, 2010K100986CALLOS BONE VOID FILLER, SKAFFOLD NEXT GENERATION BONE VOID FILLER, OSTEO VATION
Skeletal Kinetics, LLC
MQV
Jul 20, 2005K051784OSTEOVATION CMF BONE VOID FILLER
Skeletal Kinetics, LLC
GXP
Jun 3, 2005K051123CALLOS IMPACT AND INJECT BONE VOID FILLER
Skeletal Kinetics, LLC
MQV
Sep 16, 2004K042072CALLOS CMF BONE VOID FILLER
Skeletal Kinetics, LLC
GXP
May 20, 2003K030554CALLOS
Skeletal Kinetics, LLC
MQV

Latest recalls

DateFirm and productCodeLinked 510(k)
Apr 6, 2020Skeletal Kinetics, Llc
EXACTECH OSSILIX MP FIL, 10CC. Product Number: 662-02-10, UDI: 813845021051 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). Th
Terminated
MQVK112383
Apr 6, 2020Skeletal Kinetics, Llc
CRANIOSCULPT, CMF IMPACT, 10CC, Product Number: C-CMF10CC, UDI: 813845020955 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). T
Terminated
GXPK162864
Apr 6, 2020Skeletal Kinetics, Llc
CRANIOSCULPT, CMF IMPACT, 5CC, Product Number: C-CMF5CC, UDI: 813845020948 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). The
Terminated
GXPK162864
Apr 6, 2020Skeletal Kinetics, Llc
CRANIOSCULPT, CMF IMPACT, 3CC Product Number: C-CMF3CC, UDI: 813845020931 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). Thes
Terminated
GXPK162864
Apr 6, 2020Skeletal Kinetics, Llc
CRANIOSCULPT FLOW, CAN, 10CC, Product Number: C-FLOW10CC-CAN, UDI: 813845020375 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis)
Terminated
GXPK042072
Apr 6, 2020Skeletal Kinetics, Llc
SKAFFOLD RENU FLOW, 5CC. Product Number: SKMA-FL05, UDI: 813845020849 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These de
Terminated
MQVK112383
Apr 6, 2020Skeletal Kinetics, Llc
SKAFFOLD RENU FLOW, 10CC. Product Number: SKMA-FL10, UDI: 813845020856 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These d
Terminated
MQVK112383
Apr 6, 2020Skeletal Kinetics, Llc
SKAFFOLD FLOW, 10CC. Product Number: SKMX-FL10, UDI: 813845020900 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defect
Terminated
GXPK042072
Apr 6, 2020Skeletal Kinetics, Llc
SKAFFOLD FLOW (MX) 5CC. Product Number: SKMX-FL05, UDI: 813845020894 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These def
Terminated
GXPK042072
Apr 6, 2020Skeletal Kinetics, Llc
SKAFFOLD FLOW, 3CC and SKAFFOLD FLOW (MX) 3CC. Product Number: SKMX-FL03, UDI: 813845020887 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, sp
Terminated
GXPK042072
Apr 6, 2020Skeletal Kinetics, Llc
SKAFFOLD CMF IMPRESS (MP), 5CC. Product Number: CMMP-IM05, UDI: 813845020689 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). T
Terminated
MQVK100986
Apr 6, 2020Skeletal Kinetics, Llc
SKAFFOLD CMF IMPRESS (MP), 10CC. Product Number: CMMP-IM10, UDI: 813845020696 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis).
Terminated
MQVK100986
Apr 6, 2020Skeletal Kinetics, Llc
SK SKAFFOLD IMPRESS 10CC. Product Number: SKAF-IM10, UDI: 813845020795 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These d
Terminated
MQVK100986
Apr 6, 2020Skeletal Kinetics, Llc
OSTEOVATIONEX, INJECT 3CC. Product Number: 390-0003, UDI: 813845020016 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These d
Terminated
MQVK051123
Apr 6, 2020Skeletal Kinetics, Llc
OSTEOVATIONEX 5CC, INJECT FORMULA. Product Number: 390-0005, UDI: 813845020023 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis).
Terminated
MQVK051123
Apr 6, 2020Skeletal Kinetics, Llc
OSTEOVATIONEX 2CC INJECT FORMULA. Product Number: 390-0002, UDI: 813845020009 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis).
Terminated
MQVK051123
Apr 6, 2020Skeletal Kinetics, Llc
OSTEOVATION, 5CC, INJECT FORMULA. Product Number: 390-2005, UDI: 813845020054 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis).
Terminated
MQVK051123
Apr 6, 2020Skeletal Kinetics, Llc
OSTEOVATION, 5CC, IMPACT FORMULA. Product Number: 390-2105, UDI: 813845020085 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis).
Terminated
GXPK051784
Apr 6, 2020Skeletal Kinetics, Llc
OSTEOVATION, 3CC, IMPACT FORMULA. Product Number: 390-2103, UDI: 813845020078 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis).
Terminated
GXPK051784
Apr 6, 2020Skeletal Kinetics, Llc
OSTEOVATION, 10CC, INJECT FORMULA. Product Number: 390-2010, UDI: 813845020061 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis).
Terminated
GXPK051784
Apr 6, 2020Skeletal Kinetics, Llc
OSTEOVATION RMX 5CC. Product Number: 390-6001, UDI: 813845021082 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects
Terminated
GXPK051784
Apr 6, 2020Skeletal Kinetics, Llc
OSTEOVATION RMX 10CC. Product Number: 390-6002, UDI: 813845021099 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defect
Terminated
GXPK051784
Apr 6, 2020Skeletal Kinetics, Llc
OSTEOVATION IMPACT 10CC and OSTEOVATION, 10CC, IMPACT FORMULA, Product Number: 390-2110, UDI: 813845020092 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e.
Terminated
GXPK051784
Apr 6, 2020Skeletal Kinetics, Llc
OSTEOVATION EX, 5CC, IMPACT FORMULA. Product Number: 390-0205, UDI: 813845020047 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis
Terminated
MQVK100986
Apr 6, 2020Skeletal Kinetics, Llc
OSTEOVATION EX, 3CC, IMPACT FORMULA. Product Number: 390-0203, UDI: 813845020030 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis
Terminated
MQVK100986
Apr 6, 2020Skeletal Kinetics, Llc
MEDTRONIC BONE VOID FILLER, SMALL. Product Number: C07A, UDI: 813845020504 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). The
Terminated
MQVK051123
Apr 6, 2020Skeletal Kinetics, Llc
MEDTRONIC BONE VOID FILLER, LARGE. Product Number: C07B, UDI: 813845020511 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). The
Terminated
MQVK051123
Apr 6, 2020Skeletal Kinetics, Llc
EXACTECH OSSILIX FORM (MX), 5CC. Product Number: 660-01-05, UDI: 813845021020 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis).
Terminated
MQVK100986
Apr 6, 2020Skeletal Kinetics, Llc
EXACTECH OSSILIX FORM (MX), 10CC. Product Number: 660-01-10, UDI: 813845021037 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis).
Terminated
MQVK100986
Apr 6, 2020Skeletal Kinetics, Llc
EXACTECH OSSILIX FIL (MX), 5CC. Product Number: 660-02-05, UDI: 813845021006 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). T
Terminated
MQVK051123
Apr 6, 2020Skeletal Kinetics, Llc
EXACTECH OSSILIX FIL (MX), 10CC. Product Number: 660-02-10, UDI: 813845021013 - - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis)
Terminated
MQVK051123
Apr 6, 2020Skeletal Kinetics, Llc
CRANIOSCULPT, FLOW 5CC. Product Number: C-FLOW5CC, UDI: 813845020337 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These def
Terminated
GXPK042072
Apr 6, 2020Skeletal Kinetics, Llc
CRANIOSCULPT FLOW, OUS, 5CC Product Number: C-FLOW5CC-OUS, UDI: 813845020351 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). T
Terminated
GXPK042072
Apr 6, 2020Skeletal Kinetics, Llc
CRANIOSCULPT FLOW, OUS, 10CC. Product Number: C-FLOW10CC-OUS, UDI: 813845020382 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis)
Terminated
GXPK042072
Apr 6, 2020Skeletal Kinetics, Llc
CRANIOSCULPT FLOW, CAN, 5CC. Product Number: C-FLOW5CC-CAN, UDI: 813845020344 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis).
Terminated
GXPK042072
Apr 6, 2020Skeletal Kinetics, Llc
CRANIOSCULPT FLOW, 10CC. Product Number: C-FLOW10CC, UDI: 813845020368 - - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These
Terminated
GXPK042072
Apr 6, 2020Skeletal Kinetics, Llc
CRANIOSCULPT FLOW, 3CC. Product Number: C-FLOW3CC, UDI: 813845020320 - - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These d
Terminated
GXPK042072
Apr 6, 2020Skeletal Kinetics, Llc
CRANIOSCULPT C, 5CC. Product Number: C-C5CC, UDI: 813845021112 - - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects
Terminated
GXPK162864
Apr 6, 2020Skeletal Kinetics, Llc
CRANIOSCULPT C, 3CC. Product Number: C-C3CC, UDI: 813845021105 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects m
Terminated
GXPK162864
Apr 6, 2020Skeletal Kinetics, Llc
CRANIOSCULPT C, 10CC. Product Number: C-C10CC, UDI: 813845021129 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects
Terminated
GXPK162864
Apr 6, 2020Skeletal Kinetics, Llc
ACUMED IMPACT 5CC. Product Number: 65-0105-S, UDI: 813845020252 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects
Terminated
MQVK100986
Apr 6, 2020Skeletal Kinetics, Llc
ACUMED IMPACT 10CC. Product Number: 65-0110-S, UDI: 813845020269 - Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgica
Terminated
MQVK100986
Apr 6, 2020Skeletal Kinetics, Llc
ACUMED CALLOS INJECT 5CC. Product Number: 65-0005-S, UDI: 813845020238 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These d
Terminated
MQVK051123
Apr 6, 2020Skeletal Kinetics, Llc
ACUMED CALLOS INJECT 3CC. Product Number: 65-0003-S, UDI: 813845020221 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These
Terminated
MQVK051123
Apr 6, 2020Skeletal Kinetics, Llc
ACUMED CALLOS INJECT 10CC. Product Number: 65-0010-S, UDI: 813845020245 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These
Terminated
MQVK051123
Apr 3, 2020Skeletal Kinetics, Llc
Cranio/Sculpt C, 10cc, Bone Void Filler, UDI: 00813845021129 - Product Usage: CRANIO/SCULPT C is a calcium phosphate bone void filler indicated for the repair or filling of neurosurgical burr holes, o
Terminated
GXPK162864
Jun 6, 2019Skeletal Kinetics, Llc
OsteoVation, Inject, Bone Filler Kits 10cc (part number 390-2010, manufacturing lot 1130303) - Product Usage: The product provides a bone void filler that is replaced by bone during the healing proces
Terminated
GXPK051784
Jun 6, 2019Skeletal Kinetics, Llc
OsteoVation, Inject Bone Filler Kits, 5cc (part number 390-2005, manufacturing lot number 1129957) - Product Usage: The product provides a bone void filler that is replaced by bone during the healing
Terminated
GXPK051784
Jul 24, 2015Skeletal Kinetics, Llc
InjectionPlasty 1.0 Bone Void Filler; an injectable and biocompatible calcium phosphate bone void filler. Sterilized using irradiation. The single-use InjectionPlasty 1.0 Kit contains the necessary
Terminated
MQVK051123
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