EXTENSIONS-LUSATZTISCH— 510(k) K812779

Name: FDA 510(k) clearance K812779
Creator: U.S. Food and Drug Administration
Published: 1981-10-26

Substantially Equivalent

The Telos Co.

FDA 510(k) clearance K812779 for EXTENSIONS-LUSATZTISCH, Substantially Equivalent on 1981-10-26. Applicant: The Telos Co.. Device class: 1.

Clearance details

Applicant: The Telos Co.
Product code: Code HST
Device class: Class 1
Regulation: 21 CFR 888.5850
Advisory panel: Orthopedic
Date received: 1981-10-05
Decision date: 1981-10-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code HST

product code HST

Other: 1
Total: 1

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.