521-50-08

GUDID 10885862310019

AUGMENTABLE LBS III

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	10885862310019
NIH Device Record Key	932edfd3-3d73-46f6-a00f-d0dc0064161e
Commercial Distribution Status	In Commercial Distribution
Version Model Number	521-50-08
Catalog Number	521-50-08
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	10885862310019 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K100742

FDA Product Code

HAW	Neurological stereotaxic Instrument