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)

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 the device name listed in this FDA 510(k) record. The listed applicant is Tornier, Inc.. It received FDA 510(k) clearance on 2019-06-14 under 510(k) 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. The listed applicant is Tornier, Inc.. The 510(k) number is K191318.

When did AEQUALIS FLEX REVIVE Shoulder System receive FDA 510(k) clearance?

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

Who is the listed applicant for AEQUALIS FLEX REVIVE Shoulder System?

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

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

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.

NCT05500066Tornier HRS (Humeral Reconstruction System) Study (REVIVE)ENROLLING_BY_INVITATION

Other records listing Tornier, Inc. 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.

K260721Tornier Perform Advanced GlenoidK252788Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)K230352Tornier Humeral Nail and Tornier Long Humeral NailK220914Tornier Perform Humeral System – FractureK220418Tornier Perform Humeral System – Stemless

View all 19 devices →

Related Devices (Code: KWS)

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.

K260721Tornier Perform Advanced GlenoidTornier, Inc.K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.K241292MyShoulder Planner (5.3SSWPL)Medacta International S.A.K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem)Stryker Corporation (Tornier, Inc.)

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.

↑