Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer Molds— 510(k) K240856

Substantially Equivalent

Osartis GmbH

FDA 510(k) clearance K240856 for Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer Molds, Substantially Equivalent on 2024-11-20. Applicant: Osartis GmbH.

Clearance details

Applicant: Osartis GmbH
Product code: Code MBB
Advisory panel: Orthopedic
Date received: 2024-03-28
Decision date: 2024-11-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Münster, DE

Download summary PDF View on FDA.gov ↗

Adverse events under product code MBB

product code MBB

Death: 27
Injury: 1,412
Malfunction: 551
Total: 1,990

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.