Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Zavation with 71 device recalls and 15 510(k) clearances. The most recent is a device recall dated Mar 25, 2021: 10G DIRECT DOUBLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures..
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Mar 25, 2021 | 10G DIRECT DOUBLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures.Class II · Products distributed as sterile may not have been adequately sterilized | Device recalls |
| Mar 25, 2021 | ZVplasty System, 15mm, Part# VCF-1015-1. For use in Orthopedic / spinal procedures.Class II · Products distributed as sterile may not have been adequately sterilized | Device recalls |
| Mar 25, 2021 | ZVplasty Unipedicular Cement Delivery Cannula Kit, 10 Gauge, REF VCF-SCDK. For use in Orthopedic / spinal procedures.Class II · Products distributed as sterile may not have been adequately sterilized | Device recalls |
| Mar 25, 2021 | 10G SINGLE CEMENT DELIVERY KIT (5 FILLERS). For use in Orthopedic / spinal procedures.Class II · Products distributed as sterile may not have been adequately sterilized | Device recalls |
| Mar 25, 2021 | ZVplasty System, 10mm, Pat# VCF-1010-2. For use in Orthopedic / spinal procedures.Class II · Products distributed as sterile may not have been adequately sterilized | Device recalls |
| Mar 25, 2021 | ZVplasty Directional Cement Cannula (4 pieces per pack), REF VCF-1080-S4. For use in Orthopedic / spinal procedures.Class II · Products distributed as sterile may not have been adequately sterilized | Device recalls |
| Mar 25, 2021 | ZVplasty System, 15mm, Part# VCF-1015-1. For use in Orthopedic / spinal procedures.Class II · Products distributed as sterile may not have been adequately sterilized | Device recalls |
| Mar 25, 2021 | 11G DIRECT SINGLE - DELIVERY (4 FILLERS-4 SYRINGES) CODE: INTVMN-SCDK. For use in Orthopedic / spinal procedures.Class II · Products distributed as sterile may not have been adequately sterilized | Device recalls |
| Apr 4, 2017 | Zavation IBFK162206 · MAX | 510(k) clearances |
| Mar 3, 2017 | Z-LINKPC SystemK162575 · NKG | 510(k) clearances |
| Feb 17, 2017 | Z-Span Plate SystemK162824 · KWQ | 510(k) clearances |
| Oct 19, 2016 | Z-Clamp ISP SystemK161016 · PEK | 510(k) clearances |
| Apr 21, 2016 | Zavation Spinal SystemK153404 · MNH | 510(k) clearances |
| Mar 22, 2016 | Z-Span Plate SystemK160362 · KWQ | 510(k) clearances |
| Apr 29, 2015 | Zavation Posterior LEIFK142392 · MAX | 510(k) clearances |
| Dec 19, 2014 | Zavation Z-Link LumbarK142271 · OVD | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
