CONMED LINVATEC OSPREY DRILL SYSTEM— 510(k) K080444

Substantially Equivalent

Conmed Linvatec

FDA 510(k) clearance K080444 for CONMED LINVATEC OSPREY DRILL SYSTEM, Substantially Equivalent on 2008-04-02. Applicant: Conmed Linvatec.

Clearance details

Applicant: Conmed Linvatec
Product code: Code HBC
Advisory panel: Neurology
Date received: 2008-02-19
Decision date: 2008-04-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Largo, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HBC

product code HBC

Malfunction: 4,715
Total: 4,715

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.