CANNULATED LAG SCREWS— 510(k) K863119

Substantially Equivalent

Downs Surgical , Ltd.

FDA 510(k) clearance K863119 for CANNULATED LAG SCREWS, Substantially Equivalent on 1986-09-03. Applicant: Downs Surgical , Ltd..

Clearance details

Applicant: Downs Surgical , Ltd.
Product code: Code HTY
Advisory panel: Orthopedic
Date received: 1986-08-14
Decision date: 1986-09-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sheffield S9 4wj, GB

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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.