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FDA 510(k)

Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid

K-Number: K161742 · 2016-11-15

ApplicantTornier, Inc.
Decision Date2016-11-15
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid is the device name listed in this FDA 510(k) record. The listed applicant is Tornier, Inc.. It received FDA 510(k) clearance on 2016-11-15 under 510(k) number K161742. The device is classified under product code PHX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid?

Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid is a medical device that received FDA 510(k) clearance on 2016-11-15. The listed applicant is Tornier, Inc.. The 510(k) number is K161742.

When did Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid receive FDA 510(k) clearance?

Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid received FDA 510(k) clearance on 2016-11-15, under 510(k) number K161742.

Who is the listed applicant for Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid?

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 PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid?

The FDA product code for Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid is PHX.

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

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Related Devices (Code: PHX)

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.

K260556Veritas Shoulder SystemRestor3DK261683Augment Off-Axis Instrument SystemZimmer, Inc.K260102Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder SystemStryker Corporation (Tornier, Inc.)K261016MSS - Humeral reverse liners extensionMedacta International, SAK253992Veritas Reverse Total Shoulder SystemRestor3DK252404Comprehensive Reverse Shoulder - HA Glenosphere BaseplatesBiomet Orthopedics

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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