Zavation

FDA Regulatory Profile

Summary

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

Recent Recalls

NumberClassProductDate
Z-1770-2021Class IIVERTEBREX SINGLE BALLOON KIT, REF VBRX-20-SBK-10. For use in Orthopedic / spinal procedures.March 25, 2021
Z-1749-2021Class II10 GAUGE DIRECT UNILATERAL STYLET (1 X DIAMOND 1 X BEVEL) STERILE. For use in Orthopedic / spinal pMarch 25, 2021
Z-1736-2021Class II11G BEVELED TROCAR/CANNULA. For use in Orthopedic / spinal procedures.March 25, 2021
Z-1727-2021Class II10G DIRECT SINGLE - ACCESS, CODE: INTV-DWCb. For use in Orthopedic / spinal procedures.March 25, 2021
Z-1748-2021Class II10G BEVELED TROCAR/CANNULA. For use in Orthopedic / spinal procedures.March 25, 2021
Z-1763-2021Class IIZVplasty 10G, FLEX KYPHOPLASTY, REF VCF-1015-FLEX. For use in Orthopedic / spinal procedures.March 25, 2021
Z-1734-2021Class II10G DIRECT SINGLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures.March 25, 2021
Z-1746-2021Class II10 GAUGE DRILL STERILE. For use in Orthopedic / spinal procedures.March 25, 2021
Z-1700-2021Class II10 GAUGE DIRECT UNILATERAL STYLET(1 X DIAMOND 1 X BEVEL), INTVM-DSSKBD. For use in Orthopedic / spiMarch 25, 2021
Z-1760-2021Class IIZVplasty System, 15mm, Part# VCF-1015-1. For use in Orthopedic / spinal procedures.March 25, 2021
Z-1729-2021Class IIZVplasty Direct Bipedicular Bone Access Kit with Drill, 11 Gauge, REF VCF-DDBAK-11. For use in OrthMarch 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-1743-2021Class II10G DIRECT SINGLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures.March 25, 2021
Z-1733-2021Class II10G BEVELED TROCAR/CANNULA. For use in Orthopedic / spinal procedures.March 25, 2021
Z-1731-2021Class II10 Gauge Drill, CODE: INTVM-DRL. For use in Orthopedic / spinal procedures.March 25, 2021
Z-1728-2021Class IIZVplasty Direct Access Diamond Tip Trocar, 11 Gauge, REF VCF-1023-11. For use in Orthopedic / spinaMarch 25, 2021
Z-1732-2021Class IIZVplasty Cement Delivery Cannula, REF VCF-1007. For use in Orthopedic / spinal procedures.March 25, 2021
Z-1747-2021Class II10G CEMENT DELIVERY CANNULA. For use in Orthopedic / spinal procedures.March 25, 2021
Z-1769-2021Class IIVERTEBREX SINGLE BALLOON KIT, REF VBRX-15-SBK-10. For use in Orthopedic / spinal procedures.March 25, 2021
Z-1737-2021Class II11G DIAMOND TROCAR/CANNULA. For use in Orthopedic / spinal procedures.March 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