510(k) K081876— OSTEOMED RESURFACING METATARSAL IMPLANT WITH HYDROXYLAPATITE COATING

Substantially Equivalent

Osteomed LP

Clearance details

Applicant: Osteomed LP
Product code: Code KWD
Advisory panel: Orthopedic
Date received: 2008-07-02
Decision date: 2008-08-01
Decision: Substantially Equivalent
Clearance type: Special
Location: Addison, TX, US

Adverse events under product code KWD

product code KWD

Injury: 164
Total: 164

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.