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FDA 510(k)

AEQUALIS ASCEND MODULAR REVERSE SHOULDER SYSTEM

K-Number: K112615 · 2011-10-11

ApplicantTornier, Inc.
Decision Date2011-10-11
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AEQUALIS ASCEND MODULAR REVERSE 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 2011-10-11 under 510(k) number K112615. 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 ASCEND MODULAR REVERSE SHOULDER SYSTEM?

AEQUALIS ASCEND MODULAR REVERSE SHOULDER SYSTEM is a medical device that received FDA 510(k) clearance on 2011-10-11. The listed applicant is Tornier, Inc.. The 510(k) number is K112615.

When did AEQUALIS ASCEND MODULAR REVERSE SHOULDER SYSTEM receive FDA 510(k) clearance?

AEQUALIS ASCEND MODULAR REVERSE SHOULDER SYSTEM received FDA 510(k) clearance on 2011-10-11, under 510(k) number K112615.

Who is the listed applicant for AEQUALIS ASCEND MODULAR REVERSE 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 ASCEND MODULAR REVERSE SHOULDER SYSTEM?

The FDA product code for AEQUALIS ASCEND MODULAR REVERSE SHOULDER SYSTEM is PHX.

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Other records listing Tornier, Inc. as applicant

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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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