510(k) K954682— WASHER, BOLT, NUT, ORTHOPEDIC

Substantially Equivalent for Some Indications

Linvatec Corp.

Clearance details

Applicant: Linvatec Corp.
Product code: Code HTN
Advisory panel: Orthopedic
Date received: 1995-10-11
Decision date: 1996-02-09
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Largo, FL, US

Adverse events under product code HTN

product code HTN

Injury: 310
Malfunction: 639
Total: 949

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.