Skeletal Kinetics, Llc
Medical device manufacturer in Addison, TX.
10510(k) clearances
0PMA approvals
49recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K162864 | OsteoVation ImpactGXP · Traditional | 01/13/2017SE |
| K132211 | Skaffold NMX Bone Void FillerMQV · Traditional | 08/04/2014SE |
| K120354 | Beta-Tcp GranulesMQV · Traditional | 03/21/2013SE |
| K112383 | Callos Promodel Bone Void Filler, Skaffold MP (Macro Porous) Bone Void FillerMQV · Traditional | 02/07/2012SE |
| K111538 | Skaffold CisMTJ · Traditional | 10/25/2011SE |
| K100986 | Callos Bone Void Filler, Skaffold Next Generation Bone Void Filler, Osteo VationMQV · Traditional | 07/20/2010SE |
| K051784 | Osteovation CMF Bone Void FillerGXP · Special | 07/20/2005SE |
| K051123 | Callos Impact and Inject Bone Void FillerMQV · Special | 06/03/2005SE |
| K042072 | Callos CMF Bone Void FillerGXP · Traditional | 09/16/2004SE |
| K030554 | CallosMQV · Traditional | 05/20/2003SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2636-2020 Class II | EXACTECH OSSILIX MP FIL, 10CC. Product Number: 662-02-10, UDI: 813845021051 - Product…Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use… | 04/06/2020Terminated |
| Z-2635-2020 Class II | CRANIOSCULPT, CMF IMPACT, 10CC, Product Number: C-CMF10CC, UDI: 813845020955 - Product…Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use… | 04/06/2020Terminated |
| Z-2634-2020 Class II | CRANIOSCULPT, CMF IMPACT, 5CC, Product Number: C-CMF5CC, UDI: 813845020948 - Product…Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use… | 04/06/2020Terminated |
| Z-2633-2020 Class II | CRANIOSCULPT, CMF IMPACT, 3CC Product Number: C-CMF3CC, UDI: 813845020931 - Product…Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use… | 04/06/2020Terminated |
| Z-2632-2020 Class II | CRANIOSCULPT FLOW, CAN, 10CC, Product Number: C-FLOW10CC-CAN, UDI: 813845020375 -…Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use… | 04/06/2020Terminated |
| Z-2631-2020 Class II | SKAFFOLD RENU FLOW, 5CC. Product Number: SKMA-FL05, UDI: 813845020849 - Product Usage:…Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use… | 04/06/2020Terminated |
| Z-2630-2020 Class II | SKAFFOLD RENU FLOW, 10CC. Product Number: SKMA-FL10, UDI: 813845020856 - Product Usage:…Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use… | 04/06/2020Terminated |
| Z-2629-2020 Class II | SKAFFOLD FLOW, 10CC. Product Number: SKMX-FL10, UDI: 813845020900 - Product Usage:…Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use… | 04/06/2020Terminated |
| Z-2628-2020 Class II | SKAFFOLD FLOW (MX) 5CC. Product Number: SKMX-FL05, UDI: 813845020894 - Product Usage:…Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use… | 04/06/2020Terminated |
| Z-2627-2020 Class II | SKAFFOLD FLOW, 3CC and SKAFFOLD FLOW (MX) 3CC. Product Number: SKMX-FL03, UDI:…Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use… | 04/06/2020Terminated |
| Z-2626-2020 Class II | SKAFFOLD CMF IMPRESS (MP), 5CC. Product Number: CMMP-IM05, UDI: 813845020689 - Product…Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use… | 04/06/2020Terminated |
| Z-2625-2020 Class II | SKAFFOLD CMF IMPRESS (MP), 10CC. Product Number: CMMP-IM10, UDI: 813845020696 - Product…Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use… | 04/06/2020Terminated |
| Z-2624-2020 Class II | SK SKAFFOLD IMPRESS 10CC. Product Number: SKAF-IM10, UDI: 813845020795 - Product Usage:…Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use… | 04/06/2020Terminated |
| Z-2623-2020 Class II | OSTEOVATIONEX, INJECT 3CC. Product Number: 390-0003, UDI: 813845020016 - Product Usage:…Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use… | 04/06/2020Terminated |
| Z-2622-2020 Class II | OSTEOVATIONEX 5CC, INJECT FORMULA. Product Number: 390-0005, UDI: 813845020023 - Product…Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use… | 04/06/2020Terminated |
| Z-2621-2020 Class II | OSTEOVATIONEX 2CC INJECT FORMULA. Product Number: 390-0002, UDI: 813845020009 - Product…Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use… | 04/06/2020Terminated |
| Z-2620-2020 Class II | OSTEOVATION, 5CC, INJECT FORMULA. Product Number: 390-2005, UDI: 813845020054 - Product…Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use… | 04/06/2020Terminated |
| Z-2619-2020 Class II | OSTEOVATION, 5CC, IMPACT FORMULA. Product Number: 390-2105, UDI: 813845020085 - Product…Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use… | 04/06/2020Terminated |
| Z-2618-2020 Class II | OSTEOVATION, 3CC, IMPACT FORMULA. Product Number: 390-2103, UDI: 813845020078 - Product…Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use… | 04/06/2020Terminated |
| Z-2617-2020 Class II | OSTEOVATION, 10CC, INJECT FORMULA. Product Number: 390-2010, UDI: 813845020061 - Product…Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use… | 04/06/2020Terminated |
| Z-2616-2020 Class II | OSTEOVATION RMX 5CC. Product Number: 390-6001, UDI: 813845021082 - Product Usage: Callos…Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use… | 04/06/2020Terminated |
| Z-2615-2020 Class II | OSTEOVATION RMX 10CC. Product Number: 390-6002, UDI: 813845021099 - Product Usage:…Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use… | 04/06/2020Terminated |
| Z-2614-2020 Class II | OSTEOVATION IMPACT 10CC and OSTEOVATION, 10CC, IMPACT FORMULA, Product Number: 390-2110…Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use… | 04/06/2020Terminated |
| Z-2613-2020 Class II | OSTEOVATION EX, 5CC, IMPACT FORMULA. Product Number: 390-0205, UDI: 813845020047 -…Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use… | 04/06/2020Terminated |
| Z-2612-2020 Class II | OSTEOVATION EX, 3CC, IMPACT FORMULA. Product Number: 390-0203, UDI: 813845020030 -…Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use… | 04/06/2020Terminated |
| Z-2611-2020 Class II | MEDTRONIC BONE VOID FILLER, SMALL. Product Number: C07A, UDI: 813845020504 - Product…Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use… | 04/06/2020Terminated |
| Z-2610-2020 Class II | MEDTRONIC BONE VOID FILLER, LARGE. Product Number: C07B, UDI: 813845020511 - Product…Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use… | 04/06/2020Terminated |
| Z-2609-2020 Class II | EXACTECH OSSILIX FORM (MX), 5CC. Product Number: 660-01-05, UDI: 813845021020 - Product…Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use… | 04/06/2020Terminated |
| Z-2608-2020 Class II | EXACTECH OSSILIX FORM (MX), 10CC. Product Number: 660-01-10, UDI: 813845021037 - Product…Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use… | 04/06/2020Terminated |
| Z-2607-2020 Class II | EXACTECH OSSILIX FIL (MX), 5CC. Product Number: 660-02-05, UDI: 813845021006 - Product…Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use… | 04/06/2020Terminated |
| Z-2606-2020 Class II | EXACTECH OSSILIX FIL (MX), 10CC. Product Number: 660-02-10, UDI: 813845021013 - -…Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use… | 04/06/2020Terminated |
| Z-2605-2020 Class II | CRANIOSCULPT, FLOW 5CC. Product Number: C-FLOW5CC, UDI: 813845020337 - Product Usage:…Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use… | 04/06/2020Terminated |
| Z-2604-2020 Class II | CRANIOSCULPT FLOW, OUS, 5CC Product Number: C-FLOW5CC-OUS, UDI: 813845020351 - Product…Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use… | 04/06/2020Terminated |
| Z-2603-2020 Class II | CRANIOSCULPT FLOW, OUS, 10CC. Product Number: C-FLOW10CC-OUS, UDI: 813845020382 -…Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use… | 04/06/2020Terminated |
| Z-2602-2020 Class II | CRANIOSCULPT FLOW, CAN, 5CC. Product Number: C-FLOW5CC-CAN, UDI: 813845020344 - Product…Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use… | 04/06/2020Terminated |
| Z-2601-2020 Class II | CRANIOSCULPT FLOW, 10CC. Product Number: C-FLOW10CC, UDI: 813845020368 - - Product…Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use… | 04/06/2020Terminated |
| Z-2600-2020 Class II | CRANIOSCULPT FLOW, 3CC. Product Number: C-FLOW3CC, UDI: 813845020320 - - Product Usage:…Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use… | 04/06/2020Terminated |
| Z-2599-2020 Class II | CRANIOSCULPT C, 5CC. Product Number: C-C5CC, UDI: 813845021112 - - Product Usage: Callos…Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use… | 04/06/2020Terminated |
| Z-2598-2020 Class II | CRANIOSCULPT C, 3CC. Product Number: C-C3CC, UDI: 813845021105 - Product Usage: Callos…Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use… | 04/06/2020Terminated |
| Z-2597-2020 Class II | CRANIOSCULPT C, 10CC. Product Number: C-C10CC, UDI: 813845021129 - Product Usage: Callos…Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use… | 04/06/2020Terminated |
| Z-2596-2020 Class II | ACUMED IMPACT 5CC. Product Number: 65-0105-S, UDI: 813845020252 - Product Usage: Callos…Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use… | 04/06/2020Terminated |
| Z-2595-2020 Class II | ACUMED IMPACT 10CC. Product Number: 65-0110-S, UDI: 813845020269 - Callos is indicated…Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use… | 04/06/2020Terminated |
| Z-2594-2020 Class II | ACUMED CALLOS INJECT 5CC. Product Number: 65-0005-S, UDI: 813845020238 - Product Usage:…Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use… | 04/06/2020Terminated |
| Z-2593-2020 Class II | ACUMED CALLOS INJECT 3CC. Product Number: 65-0003-S, UDI: 813845020221 - Product Usage:…Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use… | 04/06/2020Terminated |
| Z-2592-2020 Class II | ACUMED CALLOS INJECT 10CC. Product Number: 65-0010-S, UDI: 813845020245 - Product Usage:…Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use… | 04/06/2020Terminated |
| Z-2054-2020 Class II | Cranio/Sculpt C, 10cc, Bone Void Filler, UDI: 00813845021129 - Product Usage:…Potential product mix-up. The recalling firm has determined that one unit of OsteoVation EX, 3cc that may… | 04/03/2020Terminated |
| Z-0867-2021 Class II | OsteoVation, Inject, Bone Filler Kits 10cc (part number 390-2010, manufacturing lot…A discrepancy was found between the Mixing Instruction Card and the Instructions for Use for the 5cc and 10… | 06/06/2019Terminated |
| Z-0866-2021 Class II | OsteoVation, Inject Bone Filler Kits, 5cc (part number 390-2005, manufacturing lot…A discrepancy was found between the Mixing Instruction Card and the Instructions for Use for the 5cc and 10… | 06/06/2019Terminated |
| Z-2209-2015 Class II | InjectionPlasty 1.0 Bone Void Filler; an injectable and biocompatible calcium phosphate…Reports of venous uptake, DVT, pulmonary embolism in patients who were implanted with Injection Plasty Bone… | 05/29/2015Terminated |