Equinoxe Ergo SPI-040722

GUDID 10885862605856

Exactech, Inc.

Glenoid orthopaedic reamer Glenoid orthopaedic reamer Glenoid orthopaedic reamer Glenoid orthopaedic reamer Glenoid orthopaedic reamer Glenoid orthopaedic reamer Glenoid orthopaedic reamer Glenoid orthopaedic reamer Glenoid orthopaedic reamer Glenoid orthopaedic reamer Glenoid orthopaedic reamer

Primary Device ID	10885862605856
NIH Device Record Key	3ad449cb-1cea-4931-9c5a-eb9d8f9394b1
Commercial Distribution Status	In Commercial Distribution
Brand Name	Equinoxe Ergo
Version Model Number	SPI-040722
Catalog Number	SPI-040722
Company DUNS	157565946
Company Name	Exactech, Inc.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10885862605856 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K063569

FDA Product Code

PHX	Shoulder Prosthesis, Reverse Configuration