FDA.report

510(k) K182536

Device
Exactech Equinoxe Small Reverse Shoulder Glenospheres , Exactech Equinoxe Reverse Shoulder Humeral Liners , Exactech Equinoxe Small Reverse Shoulder Glenoid Plates , Exactech Equinoxe Reverse Shoulder Locking Cap
Applicant
Exactech, Inc.
510(k) number
K182536
Product code
PHX  
Decision
Substantially Equivalent (SESE)
Decision date
2018-10-12
Date received
2018-09-14
Regulation
888.3660
Classification name
Shoulder Prosthesis, Reverse Configuration
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Zach Sharrah
Address
2320 NW 66th Ct. Gainesville FL US 32653 32653

FDA Registration Numbers

Source Documents

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

Legacy Summary

summary

FDA Review

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