02-521-70-0000

GUDID 10885862531858

RTKA TIBIAL ADJUSTABLE GUIDE

Exactech, Inc.

Orthopaedic stereotactic surgery system Orthopaedic stereotactic surgery system Orthopaedic stereotactic surgery system Orthopaedic stereotactic surgery system Orthopaedic stereotactic surgery system Orthopaedic stereotactic surgery system Orthopaedic stereotactic surgery system Orthopaedic stereotactic surgery system Orthopaedic stereotactic surgery system Orthopaedic stereotactic surgery system Orthopaedic stereotactic surgery system

Primary Device ID	10885862531858
NIH Device Record Key	205b6558-f667-408c-9a06-8a29e7756768
Commercial Distribution Status	In Commercial Distribution
Version Model Number	02-521-70-0000
Catalog Number	02-521-70-0000
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	10885862531858 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K100742

FDA Product Code

OLO	Orthopedic stereotaxic instrument