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FDA 510(k)

AEQUALIS UNIVERSAL SHOULDER GLENOID

K-Number: K994393 · 2000-06-22

ApplicantTornier
Decision Date2000-06-22
Product CodeKWS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AEQUALIS UNIVERSAL SHOULDER GLENOID is the device name listed in this FDA 510(k) record. The listed applicant is Tornier. It received FDA 510(k) clearance on 2000-06-22 under 510(k) number K994393. 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 UNIVERSAL SHOULDER GLENOID?

AEQUALIS UNIVERSAL SHOULDER GLENOID is a medical device that received FDA 510(k) clearance on 2000-06-22. The listed applicant is Tornier. The 510(k) number is K994393.

When did AEQUALIS UNIVERSAL SHOULDER GLENOID receive FDA 510(k) clearance?

AEQUALIS UNIVERSAL SHOULDER GLENOID received FDA 510(k) clearance on 2000-06-22, under 510(k) number K994393.

Who is the listed applicant for AEQUALIS UNIVERSAL SHOULDER GLENOID?

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

What is the FDA product code for AEQUALIS UNIVERSAL SHOULDER GLENOID?

The FDA product code for AEQUALIS UNIVERSAL SHOULDER GLENOID is KWS.

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Other records listing Tornier 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.

K112144AEQUALIS SHOULDER FRACTURE SYSTEM, AEQUALIS REVERSED SHOULDER PROSTHESIS, AEQUALIS REVERSED FRACTURE SHOULDER PROSTHESISK111970KNEETEC PFJ&HLS KNEETEC PATELLAR COMPONENTK111902AEQUALIS SHOULDER SYSTEMK094013HLS KNEETEC SYSTEMK100142AEQUALIS REVERSED SHOULDER PROSTHESISK091870TORNIER, PITON FIXATION IMPLANT SYSTEM

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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.

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