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FDA 510(k)

Medacta Shoulder System: Threaded Glenoid Baseplate

K-Number: K171058 · 2017-12-13

ApplicantMedacta International S.A.
Decision Date2017-12-13
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Medacta Shoulder System: Threaded Glenoid Baseplate is the device name listed in this FDA 510(k) record. The listed applicant is Medacta International S.A.. It received FDA 510(k) clearance on 2017-12-13 under 510(k) number K171058. 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 Medacta Shoulder System: Threaded Glenoid Baseplate?

Medacta Shoulder System: Threaded Glenoid Baseplate is a medical device that received FDA 510(k) clearance on 2017-12-13. The listed applicant is Medacta International S.A.. The 510(k) number is K171058.

When did Medacta Shoulder System: Threaded Glenoid Baseplate receive FDA 510(k) clearance?

Medacta Shoulder System: Threaded Glenoid Baseplate received FDA 510(k) clearance on 2017-12-13, under 510(k) number K171058.

Who is the listed applicant for Medacta Shoulder System: Threaded Glenoid Baseplate?

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

What is the FDA product code for Medacta Shoulder System: Threaded Glenoid Baseplate?

The FDA product code for Medacta Shoulder System: Threaded Glenoid Baseplate 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.

NCT03726554Post-Market Study of Comprehensive Reverse Augmented Glenoid and Mini Humeral Tray in Total Shoulder ArthroplastyACTIVE_NOT_RECRUITING

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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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