Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Ignite Stemless Anatomic Shoulder System

K-Number: K203108 · 2021-07-16

ApplicantIgnite Orthopedics, LLC
Decision Date2021-07-16
Product CodePKC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Ignite Stemless Anatomic Shoulder System is the device name listed in this FDA 510(k) record. The listed applicant is Ignite Orthopedics, LLC. It received FDA 510(k) clearance on 2021-07-16 under 510(k) number K203108. The device is classified under product code PKC. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ignite Stemless Anatomic Shoulder System?

Ignite Stemless Anatomic Shoulder System is a medical device that received FDA 510(k) clearance on 2021-07-16. The listed applicant is Ignite Orthopedics, LLC. The 510(k) number is K203108.

When did Ignite Stemless Anatomic Shoulder System receive FDA 510(k) clearance?

Ignite Stemless Anatomic Shoulder System received FDA 510(k) clearance on 2021-07-16, under 510(k) number K203108.

Who is the listed applicant for Ignite Stemless Anatomic Shoulder System?

The FDA 510(k) record lists Ignite Orthopedics, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ignite Stemless Anatomic Shoulder System?

The FDA product code for Ignite Stemless Anatomic Shoulder System is PKC.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07421245OsseoFit Stemless Shoulder System (Anatomic)NOT_YET_RECRUITING

Other records listing Ignite Orthopedics, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K202716Ignite Anatomic Shoulder SystemK183618Revolution Radial Head

Related Devices (Code: PKC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254154FX V135 EASYTECH® Shoulder SystemFX Shoulder Solutions, Inc.K252129AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.K243248INHANCE INTACT™Depuy Ireland UCK241873OsseoFit Stemless Shoulder SystemZimmer, Inc.K240716AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.K221758SMR Stemless AnatomicLima Corporate S.P.A.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑