Ignite Anatomic Shoulder System— 510(k) K202716

Substantially Equivalent

Ignite Orthopedics, LLC

FDA 510(k) clearance K202716 for Ignite Anatomic Shoulder System, Substantially Equivalent on 2021-05-20. Applicant: Ignite Orthopedics, LLC.

Clearance details

Applicant: Ignite Orthopedics, LLC
Product code: Code MBF
Advisory panel: Orthopedic
Date received: 2020-09-17
Decision date: 2021-05-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Winona Lake, IN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MBF

product code MBF

Injury: 597
Total: 597

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.