VERTEX Nitinol Staple System— 510(k) K182943

Name: FDA 510(k) clearance K182943
Creator: U.S. Food and Drug Administration
Published: 2019-04-04

Substantially Equivalent

Nvision Biomedical Technologies, LLC

FDA 510(k) clearance K182943 for VERTEX Nitinol Staple System, Substantially Equivalent on 2019-04-04. Applicant: Nvision Biomedical Technologies, LLC. Device class: 2.

Clearance details

Applicant: Nvision Biomedical Technologies, LLC
Product code: Code JDR
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2018-10-23
Decision date: 2019-04-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Antonio, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JDR

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K262451 — Arthrex DynaNite Staples2026-09-01
K261121 — Megalodon Dynamic Compression System2026-08-06
K250712 — Linkt Compression Staple System2025-05-14
K243888 — Medline UNITE® REFLEX® Hybrid Nitinol Implant System2025-04-11
K243742 — Arthrex DynaNite Nitinol Staples2025-01-31

More clearances from Nvision Biomedical Technologies, LLC

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K183055 — Vector Hammertoe Correction System2019-02-19
K182949 — Healix Compression Screw System2018-12-04
K180458 — FOCUS Pedicle Screw System2018-04-17
K173091 — Boundary Anterior Lumbar Buttress Plate2017-12-06
K170074 — nvc2017-01-24

Adverse events under product code JDR

product code JDR

Injury: 726
Malfunction: 663
Other: 1
Total: 1,390

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 →

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