ZVPLASTY— 510(k) K141419

Name: FDA 510(k) clearance K141419
Creator: U.S. Food and Drug Administration
Published: 2014-09-12

Substantially Equivalent

Zavation, LLC

FDA 510(k) clearance K141419 for ZVPLASTY, Substantially Equivalent on 2014-09-12. Applicant: Zavation, LLC. Device class: 2.

Clearance details

Applicant: Zavation, LLC
Product code: Code NDN
Device class: Class 2
Regulation: 21 CFR 888.3027
Advisory panel: Orthopedic
Date received: 2014-05-29
Decision date: 2014-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Flowood, MS, US

Download summary PDF View on FDA.gov ↗

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More clearances from Zavation, LLC

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K162575 — Z-LINKPC System2017-03-03
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K161016 — Z-Clamp ISP System2016-10-19
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Adverse events under product code NDN

product code NDN

Death: 24
Injury: 407
Malfunction: 1,975
Total: 2,406

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K141419

K-number listed on FDA's recall record

Z-1700-2021 — 10 GAUGE DIRECT UNILATERAL STYLET(1 X DIAMOND 1 X BEVEL), INTVM-DSSKBD. For use in Orthopedic / spinal procedures.Class II·Terminated·Zavation·20210325
Z-1702-2021 — ZVplasty Drill, 10 Gauge, REF VCF-1006. For use in Orthopedic / spinal procedures.Class II·Terminated·Zavation·20210325
Z-1703-2021 — ZVplasty Direct Access Beveled Tip Trocar, 10 Gauge, REF VCF-1022. For use in Orthopedic / spinal procedures.Class II·Terminated·Zavation·20210325
Z-1704-2021 — ZVplasty Direct Access Diamond Tip Trocar, 10 Gauge, REF VCF-1023. For use in Orthopedic / spinal procedures.Class II·Terminated·Zavation·20210325
Z-1705-2021 — ZVplasty, Bipedicular Cement Delivery Cannula Kit, 10 Gauge, REF VCF-DCDK. For use in Orthopedic / spinal procedures.Class II·Terminated·Zavation·20210325
Z-1706-2021 — ZVplasty Direct Bipedicular Bone Access Kit with Drill, 10 Gauge, VCF-DDBAK. For use in Orthopedic / spinal procedures.Class II·Terminated·Zavation·20210325
Z-1707-2021 — ZVplasty, Direct Bipedicular, Bone Access Kit with Coxaial Cannula, REF VCF-DDSKbd. For use in Orthopedic / spinal procedures.Class II·Terminated·Zavation·20210325
Z-1708-2021 — ZVplasty Direct Unipedicular Bone Access Kit with Drill, 10 Gauge, REF VCF-DSBAK. For use in Orthopedic / spinal procedures.Class II·Terminated·Zavation·20210325
Z-1709-2021 — ZVplasty Unipedicular Cement Delivery Cannula Kit, 10 Gauge, REF VCG-SCDK. For use in Orthopedic / spinal procedures.Class II·Terminated·Zavation·20210325
Z-1710-2021 — ZVplasty Bipedicular Cement Delivery Cannula, 11 Gauge, REF VCF-DCDK-11. For use in Orthopedic / spinal procedures.Class II·Terminated·Zavation·20210325
Z-1711-2021 — ZVplasty Direct Access Bevel Tip Trocar, 11 Gauge, REF VCF-1022-11. For use in Orthopedic / spinal procedures.Class II·Terminated·Zavation·20210325
Z-1712-2021 — ZVplasty Direct Access Diamond Tip Trocar, 11 Gauge, REF VCF-1023-11. For use in Orthopedic / spinal procedures.Class II·Terminated·Zavation·20210325
Z-1713-2021 — ZVplasty Direct Bipedicular Bone Access Kit with Drill, 11 Gauge, REF VCF-DDBAK-11. For use in Orthopedic / spinal procedures.Class II·Terminated·Zavation·20210325
Z-1721-2021 — ZVplasty Unipedicular Cement Delivery Cannula Kit, 10 Gauge, REF VCF-SCDK. For use in Orthopedic / spinal procedures.Class II·Terminated·Zavation·20210325
Z-1722-2021 — ZVplasty Biopsy Device, 10 Gauge, REF VCF-1010. For use in Orthopedic / spinal procedures.Class II·Terminated·Zavation·20210325
Z-1723-2021 — ZVplasty Biopsy Device, 11 Gauge, REF VCF-1010-11. For use in Orthopedic / spinal procedures.Class II·Terminated·Zavation·20210325
Z-1724-2021 — ZVplasty Direct Access Bevel Tip Trocar, 11 Gauge, REF VCF-1022-11. For use in Orthopedic / spinal procedures.Class II·Terminated·Zavation·20210325
Z-1725-2021 — ZVplasty Directional Cement Cannula Long, REF VCF-1080-L. For use in Orthopedic / spinal procedures.Class II·Terminated·Zavation·20210325
Z-1726-2021 — ZVplasty Directional Cement Cannula (4 pieces per pack), REF VCF-1080-S4. For use in Orthopedic / spinal procedures.Class II·Terminated·Zavation·20210325
Z-1728-2021 — ZVplasty Direct Access Diamond Tip Trocar, 11 Gauge, REF VCF-1023-11. For use in Orthopedic / spinal procedures.Class II·Terminated·Zavation·20210325

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K141419.

Data sourced from openFDA. This site is unofficial and independent of the FDA.