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FDA 510(k)

AEQUALIS REVERSED ADAPTER

K-Number: K071948 · 2007-10-18

ApplicantTornier
Decision Date2007-10-18
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AEQUALIS REVERSED ADAPTER is the device name listed in this FDA 510(k) record. The listed applicant is Tornier. It received FDA 510(k) clearance on 2007-10-18 under 510(k) number K071948. 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 REVERSED ADAPTER?

AEQUALIS REVERSED ADAPTER is a medical device that received FDA 510(k) clearance on 2007-10-18. The listed applicant is Tornier. The 510(k) number is K071948.

When did AEQUALIS REVERSED ADAPTER receive FDA 510(k) clearance?

AEQUALIS REVERSED ADAPTER received FDA 510(k) clearance on 2007-10-18, under 510(k) number K071948.

Who is the listed applicant for AEQUALIS REVERSED ADAPTER?

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 REVERSED ADAPTER?

The FDA product code for AEQUALIS REVERSED ADAPTER is PHX.

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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: 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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