NON-ABSORBING STERNATOMY MONOFILAMENT SUTURE— 510(k) K002755

Name: FDA 510(k) clearance K002755
Creator: U.S. Food and Drug Administration
Published: 2000-12-04

Substantially Equivalent

T. Korossurgical Instruments Corp.

FDA 510(k) clearance K002755 for NON-ABSORBING STERNATOMY MONOFILAMENT SUTURE, Substantially Equivalent on 2000-12-04. Applicant: T. Korossurgical Instruments Corp.. Device class: 2.

Clearance details

Applicant: T. Korossurgical Instruments Corp.
Product code: Code LRN
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2000-09-05
Decision date: 2000-12-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Moorepark, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code LRN

product code LRN

Injury: 185
Total: 185

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.