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FDA 510(k)

Tomier Perform™ Reversed Glenoid Cannulated Glenospheres

K-Number: K213124 · 2021-10-26

ApplicantTornier, Inc.
Decision Date2021-10-26
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Tomier Perform™ Reversed Glenoid Cannulated Glenospheres is the device name listed in this FDA 510(k) record. The listed applicant is Tornier, Inc.. It received FDA 510(k) clearance on 2021-10-26 under 510(k) number K213124. 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 Tomier Perform™ Reversed Glenoid Cannulated Glenospheres?

Tomier Perform™ Reversed Glenoid Cannulated Glenospheres is a medical device that received FDA 510(k) clearance on 2021-10-26. The listed applicant is Tornier, Inc.. The 510(k) number is K213124.

When did Tomier Perform™ Reversed Glenoid Cannulated Glenospheres receive FDA 510(k) clearance?

Tomier Perform™ Reversed Glenoid Cannulated Glenospheres received FDA 510(k) clearance on 2021-10-26, under 510(k) number K213124.

Who is the listed applicant for Tomier Perform™ Reversed Glenoid Cannulated Glenospheres?

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 Tomier Perform™ Reversed Glenoid Cannulated Glenospheres?

The FDA product code for Tomier Perform™ Reversed Glenoid Cannulated Glenospheres is PHX.

Related Clinical Trials

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.

NCT07764614Tornier Perform™ Reversed Monopost StudyNOT_YET_RECRUITING

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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