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Skeletal Kinetics, Llc

FDA Regulatory Profile

Summary

Total Recalls
49
510(k) Clearances
10
Inspections
4
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2622-2020Class IIOSTEOVATIONEX 5CC, INJECT FORMULA. Product Number: 390-0005, UDI: 813845020023 - Product Usage: CalApril 6, 2020
Z-2627-2020Class IISKAFFOLD FLOW, 3CC and SKAFFOLD FLOW (MX) 3CC. Product Number: SKMX-FL03, UDI: 813845020887 - ProduApril 6, 2020
Z-2630-2020Class IISKAFFOLD RENU FLOW, 10CC. Product Number: SKMA-FL10, UDI: 813845020856 - Product Usage: Callos is iApril 6, 2020
Z-2620-2020Class IIOSTEOVATION, 5CC, INJECT FORMULA. Product Number: 390-2005, UDI: 813845020054 - Product Usage: CallApril 6, 2020
Z-2596-2020Class IIACUMED IMPACT 5CC. Product Number: 65-0105-S, UDI: 813845020252 - Product Usage: Callos is indicateApril 6, 2020
Z-2612-2020Class IIOSTEOVATION EX, 3CC, IMPACT FORMULA. Product Number: 390-0203, UDI: 813845020030 - Product Usage: CApril 6, 2020
Z-2636-2020Class IIEXACTECH OSSILIX MP FIL, 10CC. Product Number: 662-02-10, UDI: 813845021051 - Product Usage: CallosApril 6, 2020
Z-2619-2020Class IIOSTEOVATION, 5CC, IMPACT FORMULA. Product Number: 390-2105, UDI: 813845020085 - Product Usage: CallApril 6, 2020
Z-2628-2020Class IISKAFFOLD FLOW (MX) 5CC. Product Number: SKMX-FL05, UDI: 813845020894 - Product Usage: Callos is indApril 6, 2020
Z-2605-2020Class IICRANIOSCULPT, FLOW 5CC. Product Number: C-FLOW5CC, UDI: 813845020337 - Product Usage: Callos is indApril 6, 2020
Z-2613-2020Class IIOSTEOVATION EX, 5CC, IMPACT FORMULA. Product Number: 390-0205, UDI: 813845020047 - Product Usage: CApril 6, 2020
Z-2625-2020Class IISKAFFOLD CMF IMPRESS (MP), 10CC. Product Number: CMMP-IM10, UDI: 813845020696 - Product Usage: CallApril 6, 2020
Z-2606-2020Class IIEXACTECH OSSILIX FIL (MX), 10CC. Product Number: 660-02-10, UDI: 813845021013 - - Product Usage: CaApril 6, 2020
Z-2600-2020Class IICRANIOSCULPT FLOW, 3CC. Product Number: C-FLOW3CC, UDI: 813845020320 - - Product Usage: Callos is iApril 6, 2020
Z-2604-2020Class IICRANIOSCULPT FLOW, OUS, 5CC Product Number: C-FLOW5CC-OUS, UDI: 813845020351 - Product Usage: CalloApril 6, 2020
Z-2634-2020Class IICRANIOSCULPT, CMF IMPACT, 5CC, Product Number: C-CMF5CC, UDI: 813845020948 - Product Usage: Callos April 6, 2020
Z-2616-2020Class IIOSTEOVATION RMX 5CC. Product Number: 390-6001, UDI: 813845021082 - Product Usage: Callos is indicatApril 6, 2020
Z-2621-2020Class IIOSTEOVATIONEX 2CC INJECT FORMULA. Product Number: 390-0002, UDI: 813845020009 - Product Usage: CallApril 6, 2020
Z-2611-2020Class IIMEDTRONIC BONE VOID FILLER, SMALL. Product Number: C07A, UDI: 813845020504 - Product Usage: Callos April 6, 2020
Z-2607-2020Class IIEXACTECH OSSILIX FIL (MX), 5CC. Product Number: 660-02-05, UDI: 813845021006 - Product Usage: CalloApril 6, 2020

Recent 510(k) Clearances

K-NumberDeviceDate
K162864OsteoVation ImpactJanuary 13, 2017
K132211SKAFFOLD NMX BONE VOID FILLERAugust 4, 2014
K120354BETA-TCP GRANULESMarch 21, 2013
K112383CALLOS PROMODEL BONE VOID FILLER, SKAFFOLD MP (MACRO POROUS) BONE VOID FILLERFebruary 7, 2012
K111538SKAFFOLD CISOctober 25, 2011
K100986CALLOS BONE VOID FILLER, SKAFFOLD NEXT GENERATION BONE VOID FILLER, OSTEO VATIONJuly 20, 2010
K051784OSTEOVATION CMF BONE VOID FILLERJuly 20, 2005
K051123CALLOS IMPACT AND INJECT BONE VOID FILLERJune 3, 2005
K042072CALLOS CMF BONE VOID FILLERSeptember 16, 2004
K030554CALLOSMay 20, 2003