SMOOTH OR THREADED METALLIC BONE FASTENER— 510(k) K131640

Substantially Equivalent

Biomedical Ent., Inc.

FDA 510(k) clearance K131640 for SMOOTH OR THREADED METALLIC BONE FASTENER, Substantially Equivalent on 2013-10-16. Applicant: Biomedical Ent., Inc..

Clearance details

Applicant: Biomedical Ent., Inc.
Product code: Code HTY
Advisory panel: Orthopedic
Date received: 2013-06-04
Decision date: 2013-10-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Antonio, TX, US

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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.