Optetrak SPI-009085

GUDID 10885862635006

Special Double End Patellar Drill Guide, 38/41mm

Exactech, Inc.

Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable

Primary Device ID	10885862635006
NIH Device Record Key	8ddc50d9-aa28-4a8d-bf11-baa399af0824
Commercial Distribution Status	In Commercial Distribution
Brand Name	Optetrak
Version Model Number	SPI-009085
Catalog Number	SPI-009085
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	false
Serial Number	true
Manufacturing Date	false
Expiration Date	true
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	10885862635006 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K932690

FDA Product Code

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