Equinoxe SPI-046719

GUDID 10885862622655

Ergo Angle Reamer Driver

Exactech, Inc.

Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable Bone-resection orthopaedic reamer, reusable

Primary Device ID	10885862622655
NIH Device Record Key	cdbb13ee-cd75-4a27-bceb-3565755c9794
Commercial Distribution Status	In Commercial Distribution
Brand Name	Equinoxe
Version Model Number	SPI-046719
Catalog Number	SPI-046719
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	true
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	10885862622655 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K042021

FDA Product Code

HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented