BIOSORBFX 1.5/2.0 BIOABSORBABLE FIXATION SYSTEM— 510(k) K982139

Name: FDA 510(k) clearance K982139
Creator: U.S. Food and Drug Administration
Published: 1998-09-15

Substantially Equivalent

Bionx Implants, Inc.

FDA 510(k) clearance K982139 for BIOSORBFX 1.5/2.0 BIOABSORBABLE FIXATION SYSTEM, Substantially Equivalent on 1998-09-15. Applicant: Bionx Implants, Inc.. Device class: 2.

Clearance details

Applicant: Bionx Implants, Inc.
Product code: Code JEY
Device class: Class 2
Regulation: 21 CFR 872.4760
Advisory panel: Dental
Date received: 1998-06-17
Decision date: 1998-09-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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K023022 — NUGEN FX SCREW2002-10-04
K011569 — BIOSORBFX O/M 2.0/2/4 SYSTEM2002-02-22
K013546 — MODIFICATION TO: 1.5 BONE FIXATION KIT, MODELS BXS6114, BXS62142001-11-21
K013057 — BIOCUFF,C, MODELS 236018, 236028, 2360362001-10-12
K012334 — CONTOUR MENISCUS ARROW, MODELS 541110, 541113, AND 5411162001-09-19

Adverse events under product code JEY

product code JEY

Injury: 1,542
Malfunction: 2,292
Total: 3,834

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.