Libertas Acetabular Hooded Liner— 510(k) K183365

Substantially Equivalent

Maxx Orthopedics, Inc.

FDA 510(k) clearance K183365 for Libertas Acetabular Hooded Liner, Substantially Equivalent on 2019-02-22. Applicant: Maxx Orthopedics, Inc..

Clearance details

Applicant: Maxx Orthopedics, Inc.
Product code: Code LZO
Advisory panel: Orthopedic
Date received: 2018-12-04
Decision date: 2019-02-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Norristown, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LZO

product code LZO

Death: 17
Injury: 12,942
Malfunction: 1,756
Total: 14,715

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.