MODIFICATION TO SMARTPIN— 510(k) K041288

Substantially Equivalent

Linvatec Biomaterials, Inc.

FDA 510(k) clearance K041288 for MODIFICATION TO SMARTPIN, Substantially Equivalent on 2004-06-10. Applicant: Linvatec Biomaterials, Inc..

Clearance details

Applicant: Linvatec Biomaterials, Inc.
Product code: Code HTY
Advisory panel: Orthopedic
Date received: 2004-05-13
Decision date: 2004-06-10
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.