FDA.report

510(k) K172767

Device
Zimmer Trabecular Metal Reverse Shoulder System, Mini Glenoid
Applicant
Zimmer, Inc.
510(k) number
K172767
Product code
PHX  
Decision
Substantially Equivalent (SESE)
Decision date
2017-11-30
Date received
2017-09-13
Regulation
888.3660
Classification name
Shoulder Prosthesis, Reverse Configuration
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Ehab Esmail
Address
345 E. Main St. Warsaw IN US 46580 46580

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

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Legacy Summary

summary

FDA Review

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