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FDA 510(k)

AEQUALIS FLEX REVIVE Shoulder System

K-Number: K191318 · 2019-06-14

ApplicantTornier, Inc.
Decision Date2019-06-14
Product CodeKWS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AEQUALIS FLEX REVIVE Shoulder System is a medical device manufactured by Tornier, Inc.. It received FDA 510(k) clearance on 2019-06-14 under approval number K191318. 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 FLEX REVIVE Shoulder System?

AEQUALIS FLEX REVIVE Shoulder System is a medical device that received FDA 510(k) clearance on 2019-06-14. It is manufactured by Tornier, Inc.. The 510(k) number is K191318.

When was AEQUALIS FLEX REVIVE Shoulder System approved by the FDA?

AEQUALIS FLEX REVIVE Shoulder System received FDA 510(k) clearance on 2019-06-14, under approval number K191318.

What company makes AEQUALIS FLEX REVIVE Shoulder System?

AEQUALIS FLEX REVIVE Shoulder System is manufactured by Tornier, Inc..

What is the FDA product code for AEQUALIS FLEX REVIVE Shoulder System?

The FDA product code for AEQUALIS FLEX REVIVE Shoulder System is KWS.

Related Clinical Trials

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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, Inc.

K161742Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid K160975Aequalis PerFORM+ Shoulder System K171010Latitude EV Total Elbow Arthroplasty K182461LATITUDE EV Total Elbow Arthroplasty K181587ORTHOLOC SPS Shoulder Plating System K181420Aequalis Flex Revive Shoulder System

View all 18 devices →

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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