KIRSHNER WIRES (K-WIRE) & STEINMANN PINS— 510(k) K960023

Name: FDA 510(k) clearance K960023
Creator: U.S. Food and Drug Administration
Published: 1996-03-18

Substantially Equivalent

Promex, Inc.

FDA 510(k) clearance K960023 for KIRSHNER WIRES (K-WIRE) & STEINMANN PINS, Substantially Equivalent on 1996-03-18. Applicant: Promex, Inc.. Device class: 2.

Clearance details

Applicant: Promex, Inc.
Product code: Code JDW
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 1996-01-02
Decision date: 1996-03-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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K023450 — BIOPSY SITE TISSUE MARKER DEVICE2002-12-19
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K010400 — VACUUM ASSISTED CORE BIOPSY DEVICE2001-07-24
K011270 — AUTOMATED CORE BIOPSY DEVICE2001-06-22
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Adverse events under product code JDW

product code JDW

Injury: 717
Total: 717

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.