Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Zimmer Trabecular Metal Reverse Shoulder System, Mini Glenoid

K-Number: K172767 · 2017-11-30

ApplicantZimmer, Inc.
Decision Date2017-11-30
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Zimmer Trabecular Metal Reverse Shoulder System, Mini Glenoid is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer, Inc.. It received FDA 510(k) clearance on 2017-11-30 under 510(k) number K172767. 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 Zimmer Trabecular Metal Reverse Shoulder System, Mini Glenoid?

Zimmer Trabecular Metal Reverse Shoulder System, Mini Glenoid is a medical device that received FDA 510(k) clearance on 2017-11-30. The listed applicant is Zimmer, Inc.. The 510(k) number is K172767.

When did Zimmer Trabecular Metal Reverse Shoulder System, Mini Glenoid receive FDA 510(k) clearance?

Zimmer Trabecular Metal Reverse Shoulder System, Mini Glenoid received FDA 510(k) clearance on 2017-11-30, under 510(k) number K172767.

Who is the listed applicant for Zimmer Trabecular Metal Reverse Shoulder System, Mini Glenoid?

The FDA 510(k) record lists Zimmer, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Zimmer Trabecular Metal Reverse Shoulder System, Mini Glenoid?

The FDA product code for Zimmer Trabecular Metal Reverse Shoulder System, Mini Glenoid 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.

NCT01480440Outcomes Study of the Trabecular Metal (TM) Reverse Shoulder SystemACTIVE_NOT_RECRUITINGNCT02038140Zimmer Trabecular Metal Total Ankle PMCFACTIVE_NOT_RECRUITINGNCT04984291Zimmer Biomet Shoulder Arthroplasty PMCFRECRUITINGNCT06920459Zimmer Biomet Shoulder Arthroplasty PMCF StudyRECRUITINGNCT06971497Zimmer ActivBraid Rotator Cuff Repair (RCR) StudyRECRUITINGNCT03726554Post-Market Study of Comprehensive Reverse Augmented Glenoid and Mini Humeral Tray in Total Shoulder ArthroplastyACTIVE_NOT_RECRUITING

Other records listing Zimmer, 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.

PMA P060037Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearingK261683Augment Off-Axis Instrument SystemK260831Z1 Hip SystemK251840Zimmer® Persona® Personalized Knee SystemK260182Avenir® Müller Stem; Avenir Complete™ Hip SystemK253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter)

View all 80 devices →

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.

↑