METAGEN ACTIVELOCK WIRE CERCLAGE SYSTEM— 510(k) K983976

Name: FDA 510(k) clearance K983976
Creator: U.S. Food and Drug Administration
Published: 1998-12-30

Substantially Equivalent

Metagen, LLC

FDA 510(k) clearance K983976 for METAGEN ACTIVELOCK WIRE CERCLAGE SYSTEM, Substantially Equivalent on 1998-12-30. Applicant: Metagen, LLC. Device class: 2.

Clearance details

Applicant: Metagen, LLC
Product code: Code JDQ
Device class: Class 2
Regulation: 21 CFR 888.3010
Advisory panel: Orthopedic
Date received: 1998-11-09
Decision date: 1998-12-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Menomonie, WI, US

Download summary PDF View on FDA.gov ↗

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K964003 — METAGEN ALL POLY ACETABULAR CUP SYSTEM1997-03-21
K963700 — METAGEN HIGH TIBIAL OSTEOTOMY SYSTEM1997-02-12

Adverse events under product code JDQ

product code JDQ

Death: 9
Injury: 330
Total: 339

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.