THE BONE TIE— 510(k) K982719

Substantially Equivalent

Surgicraft , Ltd.

FDA 510(k) clearance K982719 for THE BONE TIE, Substantially Equivalent on 1998-09-25. Applicant: Surgicraft , Ltd..

Clearance details

Applicant: Surgicraft , Ltd.
Product code: Code HTY
Advisory panel: Orthopedic
Date received: 1998-08-04
Decision date: 1998-09-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redditch, Worcs., 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.