201-71-12

GUDID 10885862044815

TIBIAL STEM EXTENSION DRILL, GUIDE, 12mm

Exactech, Inc.

Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable

Primary Device ID	10885862044815
NIH Device Record Key	1903d6e0-1b69-4e1a-a27b-dc15c131ce05
Commercial Distribution Status	In Commercial Distribution
Version Model Number	201-71-12
Catalog Number	201-71-12
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	10885862044815 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K012251

FDA Product Code

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