Prime and DYNASTY® Additive Manufacturing Shells— 510(k) K202705

Substantially Equivalent

Microport Orthopedics, Inc.

FDA 510(k) clearance K202705 for Prime and DYNASTY® Additive Manufacturing Shells, Substantially Equivalent on 2021-08-20. Applicant: Microport Orthopedics, Inc..

Clearance details

Applicant: Microport Orthopedics, Inc.
Product code: Code OQG
Advisory panel: Orthopedic
Date received: 2020-09-16
Decision date: 2021-08-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arlington, TN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OQG

product code OQG

Injury: 249
Total: 249

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.