REFIX PIN (PLLA), MODELS 2070L, 2770L, 3570L, 4570L; (PLGA), MODELS 2070LG, 2770LG, 3570LG, 4570LG— 510(k) K043339

Name: FDA 510(k) clearance K043339
Creator: U.S. Food and Drug Administration
Published: 2005-04-18

Substantially Equivalent

Xtremi-T, LLC

FDA 510(k) clearance K043339 for REFIX PIN (PLLA), MODELS 2070L, 2770L, 3570L, 4570L; (PLGA), MODELS 2070LG, 2770LG, 3570LG, 4570LG, Substantially Equivalent on 2005-04-18. Applicant: Xtremi-T, LLC. Device class: 2.

Clearance details

Applicant: Xtremi-T, LLC
Product code: Code HTY
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 2004-12-03
Decision date: 2005-04-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lawrenceville, NJ, US

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.