510(k) K231905— Electro-Spec Steri-Caps

Substantially Equivalent

Electro-Spec, Inc.

Clearance details

Applicant: Electro-Spec, Inc.
Product code: Code HTY
Advisory panel: Orthopedic
Date received: 2023-06-29
Decision date: 2023-08-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Franklin, IN, US

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.