205-50-05

GUDID 10885862051837

FEMORAL PS NOTCH GUIDE, SIZE 5

Exactech, Inc.

Osteotomy guide, reusable Osteotomy guide, reusable Osteotomy guide, reusable Osteotomy guide, reusable Osteotomy guide, reusable Osteotomy guide, reusable 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	10885862051837
NIH Device Record Key	5bb90fe2-663c-4c66-bb53-fdd0cb4f72da
Commercial Distribution Status	In Commercial Distribution
Version Model Number	205-50-05
Catalog Number	205-50-05
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 Dimensions

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Device Identifiers

Device Issuing Agency	Device ID
GS1	10885862051837 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K933494

FDA Product Code

JWH	PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER