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FDA 510(k)

Aequalis Fx2

K-Number: K152966 · 2016-01-14

ApplicantTornier S.A.S.
Decision Date2016-01-14
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Aequalis Fx2 is the device name listed in this FDA 510(k) record. The listed applicant is Tornier S.A.S.. It received FDA 510(k) clearance on 2016-01-14 under 510(k) number K152966. 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 Fx2?

Aequalis Fx2 is a medical device that received FDA 510(k) clearance on 2016-01-14. The listed applicant is Tornier S.A.S.. The 510(k) number is K152966.

When did Aequalis Fx2 receive FDA 510(k) clearance?

Aequalis Fx2 received FDA 510(k) clearance on 2016-01-14, under 510(k) number K152966.

Who is the listed applicant for Aequalis Fx2?

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

What is the FDA product code for Aequalis Fx2?

The FDA product code for Aequalis Fx2 is PHX.

Other records listing Tornier S.A.S. 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.

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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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