ACTIVAPIN, NEXFIX RFS PIN, NEXFIX RESORBABLE FIXATION SYSTEM (RFS)— 510(k) K071863

Substantially Equivalent

Bioretec, Ltd.

FDA 510(k) clearance K071863 for ACTIVAPIN, NEXFIX RFS PIN, NEXFIX RESORBABLE FIXATION SYSTEM (RFS), Substantially Equivalent on 2007-08-31. Applicant: Bioretec, Ltd..

Clearance details

Applicant: Bioretec, Ltd.
Product code: Code HTY
Advisory panel: Orthopedic
Date received: 2007-07-06
Decision date: 2007-08-31
Decision: Substantially Equivalent
Clearance type: Special
Location: Tampere, FI

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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.