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FDA 510(k)

Aequalis Ascend Flex Shoulder System

K-Number: K190521 · 2019-06-12

ApplicantTornier S.A.S.
Decision Date2019-06-12
Product CodeKWS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Aequalis Ascend Flex Shoulder System is a medical device manufactured by Tornier S.A.S.. It received FDA 510(k) clearance on 2019-06-12 under approval number K190521. The device is classified under product code KWS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Aequalis Ascend Flex Shoulder System?

Aequalis Ascend Flex Shoulder System is a medical device that received FDA 510(k) clearance on 2019-06-12. It is manufactured by Tornier S.A.S.. The 510(k) number is K190521.

When was Aequalis Ascend Flex Shoulder System approved by the FDA?

Aequalis Ascend Flex Shoulder System received FDA 510(k) clearance on 2019-06-12, under approval number K190521.

What company makes Aequalis Ascend Flex Shoulder System?

Aequalis Ascend Flex Shoulder System is manufactured by Tornier S.A.S..

What is the FDA product code for Aequalis Ascend Flex Shoulder System?

The FDA product code for Aequalis Ascend Flex Shoulder System is KWS.

Related Clinical Trials

NCT04816825 Home-monitored Telerehabilitation in COPD Patients COMPLETED 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 NCT07421245 OsseoFit Stemless Shoulder System (Anatomic) NOT_YET_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 Tornier S.A.S.

K161789BLUEPRINT Patient Specific Instrumentation K153452Salto XT, Salto Talaris K160555BLUEPRINT Patient Specific Instrumentation K152966Aequalis Fx2 K162800BLUEPRINT Patient Specific Instrumentation K203315BLUEPRINT™ Patient Specific Instrumentation

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Related Devices (Code: KWS)

K161789BLUEPRINT Patient Specific InstrumentationTornier S.A.S. K161863ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA), ReUnion Total Shoulder Arthroplasty (TSA)Stryker GmbH K162024AltiVate Anatomic Shoulder SystemEncore Medical L.P. K161108Arthrex VaultLock GlenoidArthrex, Inc. K160975Aequalis PerFORM+ Shoulder SystemTornier, Inc. K160555BLUEPRINT Patient Specific InstrumentationTornier S.A.S.

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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