Zavation
Flowood, MS, US
ZAVATION appears in FDA device records in Flowood, MS. FDA records list 15 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 71 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 15 510(k) clearances for Zavation between 2011 and 2017. The busiest year on record is 2011, with 3. The most recent is 2017, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2011 | 3 |
| 2012 | 1 |
| 2013 | 1 |
| 2014 | 3 |
| 2015 | 1 |
| 2016 | 3 |
| 2017 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K162206 | Zavation IBF | MAX | Substantially Equivalent | |
| K162575 | Z-LINKPC System | NKG | Substantially Equivalent | |
| K162824 | Z-Span Plate System | KWQ | Substantially Equivalent | |
| K161016 | Z-Clamp ISP System | PEK | Substantially Equivalent | |
| K153404 | Zavation Spinal System | MNH | Substantially Equivalent | |
| K160362 | Z-Span Plate System | KWQ | Substantially Equivalent | |
| K142392 | Zavation Posterior LEIF | MAX | Substantially Equivalent | |
| K142271 | Zavation Z-Link Lumbar | OVD | Substantially Equivalent | |
| K141419 | ZVPLASTY | NDN | Substantially Equivalent | |
| K141005 | Z-LINK CERVICAL | OVE | Substantially Equivalent | |
| K130030 | ZAVATION CERVICAL PLATE SYSTEM | KWQ | Substantially Equivalent | |
| K120576 | ZAVATION IBF SYSTEM | MAX | Substantially Equivalent | |
| K112664 | ZAVATION IBF SYSTEMS | ODP | Substantially Equivalent | |
| K112533 | ZAVATION CERVICAL PLATE SYSTEM | KWQ | Substantially Equivalent | |
| K112484 | ZAVATION SPINAL SYSTEM | MNI | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3008583793 | 3008583793 | ZAVATION | 3670 Flowood Dr, Flowood, MS 39232 US | 2026 | and 37 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- LYQAccessories, Fixation, Spinal Intervertebral Body
- KWPAppliance, Fixation, Spinal Interlaminal
- KWQAppliance, Fixation, Spinal Intervertebral Body
- HRXArthroscope
- HWJAwl
- HXWBender
- HTWBit, Drill
- HTQBroach
- KTZCaliper
- NDNCement, Bone, Vertebroplasty
- HTFCurette
- HXZCutter, Wire
- MQVFiller, Bone Void, Calcium Compound
- HTJGauge, Depth
- OARInjector, Vertebroplasty (Does Not Contain Cement)
- HXPInstrument, Bending Or Contouring
- HWNInstrument, Compression
- ODPIntervertebral Fusion Device With Bone Graft, Cervical
- MAXIntervertebral Fusion Device With Bone Graft, Lumbar
- OVEIntervertebral Fusion Device With Integrated Fixation, Cervical
- OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar
- JDZMixer, Cement, For Clinical Use
- GAANeedle, Aspiration And Injection, Disposable
- LXHOrthopedic Manual Surgical Instrument
- OLOOrthopedic Stereotaxic Instrument
- MNIOrthosis, Spinal Pedicle Fixation
- MNHOrthosis, Spondylolisthesis Spinal Fixation
- HWMOsteotome
- HXIPasser, Wire, Orthopedic
- NKGPosterior Cervical Screw System
- HXBProbe
- GACRasp, Surgical, General & Plastic Surgery
- HTOReamer
- HTXRongeur
- OURSacroiliac Joint Fixation
- HWCScrew, Fixation, Bone
- HXXScrewdriver
- OCJSpinal Channeling Instrument, Vertebroplasty
- MQPSpinal Vertebral Body Replacement Device
- PLRSpinal Vertebral Body Replacement Device - Cervical
- PEKSpinous Process Plate
- MRWSystem, Facet Screw Spinal Device
- HXGTamp
- HWXTap, Bone
- HWTTemplate
- NKBThoracolumbosacral Pedicle Screw System
- HXCWrench
Recall records
Showing 25 of 71| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1770-2021 | VERTEBREX SINGLE BALLOON KIT, REF VBRX-20-SBK-10. For use in Orthopedic / spinal procedures. | Products distributed as sterile may not have been adequately sterilized | Class II | Terminated | |
| Z-1769-2021 | VERTEBREX SINGLE BALLOON KIT, REF VBRX-15-SBK-10. For use in Orthopedic / spinal procedures. | Products distributed as sterile may not have been adequately sterilized | Class II | Terminated | |
| Z-1768-2021 | OsteoFlex Cement and Mixing System, REF VCF-OSFL. For use in Orthopedic / spinal procedures. | Products distributed as sterile may not have been adequately sterilized | Class II | Terminated | |
| Z-1767-2021 | ZVPlasty, 11G, 15mm Traditional Bipedicular Kit, REF VCF-1115-2. For use in Orthopedic / spinal procedures. | Products distributed as sterile may not have been adequately sterilized | Class II | Terminated | |
| Z-1766-2021 | ZVplasty System, 20mm, Part# VCF-1020-2. For use in Orthopedic / spinal procedures. | Products distributed as sterile may not have been adequately sterilized | Class II | Terminated | |
| Z-1765-2021 | ZVplasty 10G, 20mm, Traditional Unipedicular Kit, REF VCF-1020-1. For use in Orthopedic / spinal procedures. | Products distributed as sterile may not have been adequately sterilized | Class II | Terminated | |
| Z-1764-2021 | ZVplasty 10G, 15mm Single Balloon Kit, REF VCF-SBK. For use in Orthopedic / spinal procedures. | Products distributed as sterile may not have been adequately sterilized | Class II | Terminated | |
| Z-1763-2021 | ZVplasty 10G, FLEX KYPHOPLASTY, REF VCF-1015-FLEX. For use in Orthopedic / spinal procedures. | Products distributed as sterile may not have been adequately sterilized | Class II | Terminated | |
| Z-1762-2021 | ZVplasty System, 15mm, Part Numbers: a) VCF-1015-2 b) VCF-1015-2A. For use in Orthopedic / spinal procedures. | Products distributed as sterile may not have been adequately sterilized | Class II | Terminated | |
| Z-1761-2021 | ZVplasty 10G, 15mm, Additional Level Kit, REF VCF-1015-1A. For use in Orthopedic / spinal procedures. | Products distributed as sterile may not have been adequately sterilized | Class II | Terminated | |
| Z-1760-2021 | ZVplasty System, 15mm, Part# VCF-1015-1. For use in Orthopedic / spinal procedures. | Products distributed as sterile may not have been adequately sterilized | Class II | Terminated | |
| Z-1759-2021 | ZVplasty System, 15mm, Part# VCF-1015-1. For use in Orthopedic / spinal procedures. | Products distributed as sterile may not have been adequately sterilized | Class II | Terminated | |
| Z-1758-2021 | ZVplasty, 10G, 10mm Double Balloon Kit, REF VCF-1010-DBK. For use in Orthopedic / spinal procedures. | Products distributed as sterile may not have been adequately sterilized | Class II | Terminated | |
| Z-1757-2021 | ZVplasty System, 10mm, Pat# VCF-1010-2. For use in Orthopedic / spinal procedures. | Products distributed as sterile may not have been adequately sterilized | Class II | Terminated | |
| Z-1756-2021 | OsteoFlex BONE CEMENT, REF Numbers: a) INTV-OSFL b) INTV-OSFL-LV. For use in Orthopedic / spinal procedures. | Products distributed as sterile may not have been adequately sterilized | Class II | Terminated | |
| Z-1755-2021 | InterV 11G Kyphoplasty Kit, REF Numbers: a) INTVMN-10-DSK b) INTVMN-15-DSK c) INTVMN-15-DSKC d) INTVMN-20-DSK. For use in Orthopedic / spinal procedures. | Products distributed as sterile may not have been adequately sterilized | Class II | Terminated | |
| Z-1754-2021 | InterV 10G Bone Access Tools/Kit, REF INTVM-FLNK. For use in Orthopedic / spinal procedures. | Products distributed as sterile may not have been adequately sterilized | Class II | Terminated | |
| Z-1753-2021 | InterV CurvePlus Kit, REF Numbers: a) INTVMC-15-FLDSK b) INTVMC-20-FLDSK. For use in Orthopedic / spinal procedures. | Products distributed as sterile may not have been adequately sterilized | Class II | Terminated | |
| Z-1752-2021 | InterV, 10G FLEX Kyphoplasty, REF Number: a) INTVM-15-FLDSK b) INTVM-20-FLDSK. For use in Orthopedic / spinal procedures. | Products distributed as sterile may not have been adequately sterilized | Class II | Terminated | |
| Z-1751-2021 | InterV, 10G Kyphoplasty Kits, REF numbers: a) INTVM-10-DSK b) INTVM-10-SBK c) INTVM-15-DSK d) INTVM-15-DSKC e) INTVM-15-SBK f) INTVM-15-SIKBC g) INTVM-20-DSK h) INTVM-20-SBK. For use in Orthopedic / spinal procedures. | Products distributed as sterile may not have been adequately sterilized | Class II | Terminated | |
| Z-1750-2021 | CEMIX - CEMENT MIXING SYSTEM STERILE, CODE INTV-MMS. For use in Orthopedic / spinal procedures. | Products distributed as sterile may not have been adequately sterilized | Class II | Terminated | |
| Z-1749-2021 | 10 GAUGE DIRECT UNILATERAL STYLET (1 X DIAMOND 1 X BEVEL) STERILE. For use in Orthopedic / spinal procedures. | Products distributed as sterile may not have been adequately sterilized | Class II | Terminated | |
| Z-1748-2021 | 10G BEVELED TROCAR/CANNULA. For use in Orthopedic / spinal procedures. | Products distributed as sterile may not have been adequately sterilized | Class II | Terminated | |
| Z-1747-2021 | 10G CEMENT DELIVERY CANNULA. For use in Orthopedic / spinal procedures. | Products distributed as sterile may not have been adequately sterilized | Class II | Terminated | |
| Z-1746-2021 | 10 GAUGE DRILL STERILE. For use in Orthopedic / spinal procedures. | Products distributed as sterile may not have been adequately sterilized | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain