PLLA PIN— 510(k) K010983

Name: FDA 510(k) clearance K010983
Creator: U.S. Food and Drug Administration
Published: 2001-06-13

Substantially Equivalent

Bionx Implants, Inc.

FDA 510(k) clearance K010983 for PLLA PIN, Substantially Equivalent on 2001-06-13. 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: 2001-04-02
Decision date: 2001-06-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Tampere, FI

Download summary PDF View on FDA.gov ↗

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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.