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
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 13, 2017 | K162864 | OsteoVation Impact Skeletal Kinetics, LLC | GXP |
| Aug 4, 2014 | K132211 | SKAFFOLD NMX BONE VOID FILLER Skeletal Kinetics, LLC | MQV |
| Mar 21, 2013 | K120354 | BETA-TCP GRANULES Skeletal Kinetics, LLC | MQV |
| Feb 7, 2012 | K112383 | CALLOS PROMODEL BONE VOID FILLER, SKAFFOLD MP (MACRO POROUS) BONE VOID FILLER Skeletal Kinetics, LLC | MQV |
| Oct 25, 2011 | K111538 | SKAFFOLD CIS Skeletal Kinetics, LLC | MTJ |
| Jul 20, 2010 | K100986 | CALLOS BONE VOID FILLER, SKAFFOLD NEXT GENERATION BONE VOID FILLER, OSTEO VATION Skeletal Kinetics, LLC | MQV |
| Jul 20, 2005 | K051784 | OSTEOVATION CMF BONE VOID FILLER Skeletal Kinetics, LLC | GXP |
| Jun 3, 2005 | K051123 | CALLOS IMPACT AND INJECT BONE VOID FILLER Skeletal Kinetics, LLC | MQV |
| Sep 16, 2004 | K042072 | CALLOS CMF BONE VOID FILLER Skeletal Kinetics, LLC | GXP |
| May 20, 2003 | K030554 | CALLOS Skeletal Kinetics, LLC | MQV |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 6, 2020 | Skeletal 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 |
MQV | K112383 |
| Apr 6, 2020 | Skeletal 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 |
GXP | K162864 |
| Apr 6, 2020 | Skeletal 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 |
GXP | K162864 |
| Apr 6, 2020 | Skeletal 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 |
GXP | K162864 |
| Apr 6, 2020 | Skeletal 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 |
GXP | K042072 |
| Apr 6, 2020 | Skeletal 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 |
MQV | K112383 |
| Apr 6, 2020 | Skeletal 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 |
MQV | K112383 |
| Apr 6, 2020 | Skeletal 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 |
GXP | K042072 |
| Apr 6, 2020 | Skeletal 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 |
GXP | K042072 |
| Apr 6, 2020 | Skeletal 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 |
GXP | K042072 |
| Apr 6, 2020 | Skeletal 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 |
MQV | K100986 |
| Apr 6, 2020 | Skeletal 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 |
MQV | K100986 |
| Apr 6, 2020 | Skeletal 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 |
MQV | K100986 |
| Apr 6, 2020 | Skeletal 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 |
MQV | K051123 |
| Apr 6, 2020 | Skeletal 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 |
MQV | K051123 |
| Apr 6, 2020 | Skeletal 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 |
MQV | K051123 |
| Apr 6, 2020 | Skeletal 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 |
MQV | K051123 |
| Apr 6, 2020 | Skeletal 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 |
GXP | K051784 |
| Apr 6, 2020 | Skeletal 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 |
GXP | K051784 |
| Apr 6, 2020 | Skeletal 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 |
GXP | K051784 |
| Apr 6, 2020 | Skeletal 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 |
GXP | K051784 |
| Apr 6, 2020 | Skeletal 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 |
GXP | K051784 |
| Apr 6, 2020 | Skeletal 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 |
GXP | K051784 |
| Apr 6, 2020 | Skeletal 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 |
MQV | K100986 |
| Apr 6, 2020 | Skeletal 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 |
MQV | K100986 |
| Apr 6, 2020 | Skeletal 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 |
MQV | K051123 |
| Apr 6, 2020 | Skeletal 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 |
MQV | K051123 |
| Apr 6, 2020 | Skeletal 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 |
MQV | K100986 |
| Apr 6, 2020 | Skeletal 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 |
MQV | K100986 |
| Apr 6, 2020 | Skeletal 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 |
MQV | K051123 |
| Apr 6, 2020 | Skeletal 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 |
MQV | K051123 |
| Apr 6, 2020 | Skeletal 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 |
GXP | K042072 |
| Apr 6, 2020 | Skeletal 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 |
GXP | K042072 |
| Apr 6, 2020 | Skeletal 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 |
GXP | K042072 |
| Apr 6, 2020 | Skeletal 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 |
GXP | K042072 |
| Apr 6, 2020 | Skeletal 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 |
GXP | K042072 |
| Apr 6, 2020 | Skeletal 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 |
GXP | K042072 |
| Apr 6, 2020 | Skeletal 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 |
GXP | K162864 |
| Apr 6, 2020 | Skeletal 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 |
GXP | K162864 |
| Apr 6, 2020 | Skeletal 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 |
GXP | K162864 |
| Apr 6, 2020 | Skeletal 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 |
MQV | K100986 |
| Apr 6, 2020 | Skeletal 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 |
MQV | K100986 |
| Apr 6, 2020 | Skeletal 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 |
MQV | K051123 |
| Apr 6, 2020 | Skeletal 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 |
MQV | K051123 |
| Apr 6, 2020 | Skeletal 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 |
MQV | K051123 |
| Apr 3, 2020 | Skeletal 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 |
GXP | K162864 |
| Jun 6, 2019 | Skeletal 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 |
GXP | K051784 |
| Jun 6, 2019 | Skeletal 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 |
GXP | K051784 |
| Jul 24, 2015 | Skeletal 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 |
MQV | K051123 |