Ignite Stemless Anatomic Shoulder System— 510(k) K203108

Substantially Equivalent

Ignite Orthopedics, LLC

FDA 510(k) clearance K203108 for Ignite Stemless Anatomic Shoulder System, Substantially Equivalent on 2021-07-16. Applicant: Ignite Orthopedics, LLC.

Clearance details

Applicant: Ignite Orthopedics, LLC
Product code: Code PKC
Advisory panel: Orthopedic
Date received: 2020-10-15
Decision date: 2021-07-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Winona Lake, IN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code PKC

product code PKC

Injury: 258
Total: 258

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.