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Zavation

FDA Regulatory Profile

Zavation appears in FDA public data with 71 recalls, 15 510(k) clearances, 3 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1757-2021, Class II) was initiated on March 25, 2021. Its most recent 510(k) clearance was granted on April 4, 2017.

Summary

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

Recent Recalls

NumberClassProductDate
Z-1757-2021Class IIZVplasty System, 10mm, Pat# VCF-1010-2. For use in Orthopedic / spinal procedures.March 25, 2021
Z-1741-2021Class II10G DOUBLE CEMENT DELIVERY KIT (8 FILLERS). For use in Orthopedic / spinal procedures.March 25, 2021
Z-1701-2021Class II10 GAUGE CEMENT DELIVERY CANNULA, INTVM-CDC. For use in Orthopedic / spinal procedures.March 25, 2021
Z-1721-2021Class IIZVplasty Unipedicular Cement Delivery Cannula Kit, 10 Gauge, REF VCF-SCDK. For use in Orthopedic / March 25, 2021
Z-1722-2021Class IIZVplasty Biopsy Device, 10 Gauge, REF VCF-1010. For use in Orthopedic / spinal procedures.March 25, 2021
Z-1756-2021Class IIOsteoFlex BONE CEMENT, REF Numbers: a) INTV-OSFL b) INTV-OSFL-LV. For use in Orthopedic / spinaMarch 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-1706-2021Class IIZVplasty Direct Bipedicular Bone Access Kit with Drill, 10 Gauge, VCF-DDBAK. For use in Orthopedic March 25, 2021
Z-1724-2021Class IIZVplasty Direct Access Bevel Tip Trocar, 11 Gauge, REF VCF-1022-11. For use in Orthopedic / spinal March 25, 2021
Z-1770-2021Class IIVERTEBREX SINGLE BALLOON KIT, REF VBRX-20-SBK-10. 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-1750-2021Class IICEMIX - CEMENT MIXING SYSTEM STERILE, CODE INTV-MMS. For use in Orthopedic / spinal procedures.March 25, 2021
Z-1730-2021Class II10 G Coxaxial Cannula with Tuohy Connection, CODE: INTVM-CC. For use in Orthopedic / spinal proceduMarch 25, 2021
Z-1766-2021Class IIZVplasty System, 20mm, Part# VCF-1020-2. For use in Orthopedic / spinal procedures.March 25, 2021
Z-1740-2021Class II10G SINGLE CEMENT DELIVERY KIT (5 FILLERS). For use in Orthopedic / spinal procedures.March 25, 2021
Z-1719-2021Class II11G DIRECT WORKING CANNULA DIAMOND TIP MINI, CODE: INTVMN-DWCD. For use in Orthopedic / spinal procMarch 25, 2021
Z-1739-2021Class II11G DIRECT DOUBLE BONE ACCESS KIT. 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-1748-2021Class II10G BEVELED TROCAR/CANNULA. For use in Orthopedic / spinal procedures.March 25, 2021
Z-1720-2021Class II10 GAUGE SINGLE CEMENT DELIVERY 4 FILLERS 4 SYRINGES, CODE: INTVM-SCDK. For use in Orthopedic / spiMarch 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

FDA data resources