700000357480

GUDID 07613327468311

Crest Drill Guide

MAKO SURGICAL CORP.

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Primary Device ID	07613327468311
NIH Device Record Key	c5af44a0-7b74-4459-b63c-6eb775a4288e
Commercial Distribution Status	In Commercial Distribution
Version Model Number	700000357480
Catalog Number	700000357480
Company DUNS	175239677
Company Name	MAKO SURGICAL CORP.
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

Customer Support Contacts

Phone	+1(954)628-0802
Email	MakoCustomerService@stryker.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327468311 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K193128

FDA Product Code

OLO	Orthopedic stereotaxic instrument