PLGA PIN, MODEL 171120,171140,171520,171540,171560,172020,172040,172060,173240,173260— 510(k) K003659

Name: FDA 510(k) clearance K003659
Creator: U.S. Food and Drug Administration
Published: 2001-02-20

Substantially Equivalent

Bionx Implants, Inc.

FDA 510(k) clearance K003659 for PLGA PIN, MODEL 171120,171140,171520,171540,171560,172020,172040,172060,173240,173260, Substantially Equivalent on 2001-02-20. Applicant: Bionx Implants, Inc.. Device class: 2.

Clearance details

Applicant: Bionx Implants, Inc.
Product code: Code HTY
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 2000-11-28
Decision date: 2001-02-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tampere, FI

Download summary PDF View on FDA.gov ↗

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K013057 — BIOCUFF,C, MODELS 236018, 236028, 2360362001-10-12
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Adverse events under product code HTY

product code HTY

Injury: 544
Total: 544

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.