REMEDY Acetabular Cup— 510(k) K191981

Substantially Equivalent

Osteoremedies, LLC

FDA 510(k) clearance K191981 for REMEDY Acetabular Cup, Substantially Equivalent on 2019-08-23. Applicant: Osteoremedies, LLC.

Clearance details

Applicant: Osteoremedies, LLC
Product code: Code KWL
Advisory panel: Orthopedic
Date received: 2019-07-24
Decision date: 2019-08-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Germantown, TN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KWL

product code KWL

Injury: 523
Total: 523

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.