ACTIVAPIN HT, FUSE LINK (PRIVATE LABLED FOR FOOTMIND, INC.)— 510(k) K133950

Substantially Equivalent

Bioretec, Ltd.

FDA 510(k) clearance K133950 for ACTIVAPIN HT, FUSE LINK (PRIVATE LABLED FOR FOOTMIND, INC.), Substantially Equivalent on 2014-01-22. Applicant: Bioretec, Ltd..

Clearance details

Applicant: Bioretec, Ltd.
Product code: Code HTY
Advisory panel: Orthopedic
Date received: 2013-12-23
Decision date: 2014-01-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Tampere, FI

Download summary PDF View on FDA.gov ↗

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.