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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 a medical device manufactured by Ignite Orthopedics, LLC. It received FDA 510(k) clearance on 2021-07-16 under approval 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. It is manufactured by Ignite Orthopedics, LLC. The 510(k) number is K203108.

When was Ignite Stemless Anatomic Shoulder System approved by the FDA?

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

What company makes Ignite Stemless Anatomic Shoulder System?

Ignite Stemless Anatomic Shoulder System is manufactured by Ignite Orthopedics, LLC.

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

NCT04816825 Home-monitored Telerehabilitation in COPD Patients COMPLETED NCT06323980 INHANCE Stemless Reverse Shoulder IDE RECRUITING NCT05951491 Improving Arm Function Using Wearable Exoskeletons SUSPENDED NCT04984291 Zimmer Biomet Shoulder Arthroplasty PMCF RECRUITING NCT01480440 Outcomes Study of the Trabecular Metal (TM) Reverse Shoulder System ACTIVE_NOT_RECRUITING NCT07550543 PEMF Therapy in Shoulder Tendinopathy RECRUITING

Related PubMed Literature

PMID: 42173476 Feasibility of applying the Orthopaedic Data Evaluation Panel (ODEP) shoulder criteria for implants used in a United States-based integrated healthcare system. Journal of shoulder and elbow surgery (2026)

Other Devices by Ignite Orthopedics, LLC

K202716Ignite Anatomic Shoulder System

Related Devices (Code: PKC)

K171858Sidus Stem-Free ShoulderZimmer GmbH K173388Exactech Equinoxe Stemless ShoulderExactech, Inc. K182516Comprehensive Nano Stemless ShoulderBiomet Manufacturing Corp K203100Arthrex Eclipse Titanium Humeral HeadArthrex, Inc. K201542Arthrex Eclipse Shoulder Prosthesis SystemArthrex, Inc. K193226AltiVate Anatomic Canal-Sparing (CS) ShoulderEncore Medical L.P.

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.

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