Optetrak 213-50-54

GUDID 10885862228383

Exactech, Inc.

Osteotomy guide Osteotomy guide Osteotomy guide Osteotomy guide Osteotomy guide Osteotomy guide Osteotomy guide Osteotomy guide Osteotomy guide, reusable Osteotomy guide Osteotomy guide, reusable Osteotomy guide Osteotomy guide, reusable Osteotomy guide Osteotomy guide, reusable Osteotomy guide Osteotomy guide, reusable Osteotomy guide Osteotomy guide, reusable Osteotomy guide Osteotomy guide, reusable Osteotomy guide, reusable Osteotomy guide, reusable Osteotomy guide, reusable Osteotomy guide, reusable Osteotomy guide, reusable Osteotomy guide, reusable Osteotomy guide, reusable

Primary Device ID	10885862228383
NIH Device Record Key	1d97c968-cbc1-4734-abb3-f1dfbd3b7d7c
Commercial Distribution Status	In Commercial Distribution
Brand Name	Optetrak
Version Model Number	213-50-54
Catalog Number	213-50-54
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

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Device Identifiers

Device Issuing Agency	Device ID
GS1	10885862228383 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K171045

FDA Product Code

JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer