Zavation

FDA Regulatory Profile

Summary

Total Recalls
71
510(k) Clearances
15
Inspections
3
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1741-2021Class II10G DOUBLE CEMENT DELIVERY KIT (8 FILLERS). For use in Orthopedic / spinal procedures.March 25, 2021
Z-1732-2021Class IIZVplasty Cement Delivery Cannula, REF VCF-1007. For use in Orthopedic / spinal procedures.March 25, 2021
Z-1704-2021Class IIZVplasty Direct Access Diamond Tip Trocar, 10 Gauge, REF VCF-1023. For use in Orthopedic / spinal pMarch 25, 2021
Z-1758-2021Class IIZVplasty, 10G, 10mm Double Balloon Kit, REF VCF-1010-DBK. For use in Orthopedic / spinal proceduresMarch 25, 2021
Z-1727-2021Class II10G DIRECT SINGLE - ACCESS, CODE: INTV-DWCb. For use in Orthopedic / spinal procedures.March 25, 2021
Z-1708-2021Class IIZVplasty Direct Unipedicular Bone Access Kit with Drill, 10 Gauge, REF VCF-DSBAK. For use in OrthopMarch 25, 2021
Z-1739-2021Class II11G DIRECT DOUBLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures.March 25, 2021
Z-1755-2021Class IIInterV 11G Kyphoplasty Kit, REF Numbers: a) INTVMN-10-DSK b) INTVMN-15-DSK c) INTVMN-15-DSKC March 25, 2021
Z-1726-2021Class IIZVplasty Directional Cement Cannula (4 pieces per pack), REF VCF-1080-S4. For use in Orthopedic / sMarch 25, 2021
Z-1715-2021Class II10G DIRECT SINGLE - ACCESS, CODE INTVM-DSBAK. For use in Orthopedic / spinal procedures.March 25, 2021
Z-1709-2021Class IIZVplasty Unipedicular Cement Delivery Cannula Kit, 10 Gauge, REF VCG-SCDK. For use in Orthopedic / March 25, 2021
Z-1751-2021Class IIInterV, 10G Kyphoplasty Kits, REF numbers: a) INTVM-10-DSK b) INTVM-10-SBK c) INTVM-15-DSK d) INMarch 25, 2021
Z-1762-2021Class IIZVplasty System, 15mm, Part Numbers: a) VCF-1015-2 b) VCF-1015-2A. For use in Orthopedic / spiMarch 25, 2021
Z-1753-2021Class IIInterV CurvePlus Kit, REF Numbers: a) INTVMC-15-FLDSK b) INTVMC-20-FLDSK. For use in Orthopedic March 25, 2021
Z-1765-2021Class IIZVplasty 10G, 20mm, Traditional Unipedicular Kit, REF VCF-1020-1. For use in Orthopedic / spinal prMarch 25, 2021
Z-1759-2021Class IIZVplasty System, 15mm, Part# VCF-1015-1. For use in Orthopedic / spinal procedures.March 25, 2021
Z-1717-2021Class II11G DIRECT SINGLE - DELIVERY (4 FILLERS-4 SYRINGES) CODE: INTVMN-SCDK. For use in Orthopedic / spMarch 25, 2021
Z-1721-2021Class IIZVplasty Unipedicular Cement Delivery Cannula Kit, 10 Gauge, REF VCF-SCDK. For use in Orthopedic / March 25, 2021
Z-1703-2021Class IIZVplasty Direct Access Beveled Tip Trocar, 10 Gauge, REF VCF-1022. For use in Orthopedic / spinal pMarch 25, 2021
Z-1728-2021Class IIZVplasty Direct Access Diamond Tip Trocar, 11 Gauge, REF VCF-1023-11. For use in Orthopedic / spinaMarch 25, 2021

Recent 510(k) Clearances

K-NumberDeviceDate
K162206Zavation IBFApril 4, 2017
K162575Z-LINKPC SystemMarch 3, 2017
K162824Z-Span Plate SystemFebruary 17, 2017
K161016Z-Clamp ISP SystemOctober 19, 2016
K153404Zavation Spinal SystemApril 21, 2016
K160362Z-Span Plate SystemMarch 22, 2016
K142392Zavation Posterior LEIFApril 29, 2015
K142271Zavation Z-Link LumbarDecember 19, 2014
K141419ZVPLASTYSeptember 12, 2014
K141005Z-LINK CERVICALAugust 7, 2014
K130030ZAVATION CERVICAL PLATE SYSTEMApril 25, 2013
K120576ZAVATION IBF SYSTEMMarch 28, 2012
K112664ZAVATION IBF SYSTEMSDecember 23, 2011
K112533ZAVATION CERVICAL PLATE SYSTEMDecember 8, 2011
K112484ZAVATION SPINAL SYSTEMNovember 22, 2011