PROFEMUR GLADIATOR Thin HA Classic Hip Stem with Collar— 510(k) K200007

Substantially Equivalent

Microport Orthopedics, Inc.

FDA 510(k) clearance K200007 for PROFEMUR GLADIATOR Thin HA Classic Hip Stem with Collar, Substantially Equivalent on 2020-04-25. Applicant: Microport Orthopedics, Inc..

Clearance details

Applicant: Microport Orthopedics, Inc.
Product code: Code LZO
Advisory panel: Orthopedic
Date received: 2020-01-02
Decision date: 2020-04-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arlington, TN, 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.