ACCOLADE II 210433-2740

GUDID 00848486028084

127¿ 40mm NECK TRIAL

MAKO SURGICAL CORP.

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Primary Device ID	00848486028084
NIH Device Record Key	b100c7a0-1926-492c-96a0-2f2eb03ea5ff
Commercial Distribution Status	In Commercial Distribution
Brand Name	ACCOLADE II
Version Model Number	210433-2740
Catalog Number	210433-2740
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

Device Dimensions

Length	40 Millimeter
Length	40 Millimeter
Device Size Text, specify	0
Length	40 Millimeter
Device Size Text, specify	0
Length	40 Millimeter
Device Size Text, specify	0
Length	40 Millimeter
Device Size Text, specify	0
Length	40 Millimeter
Device Size Text, specify	0
Length	40 Millimeter
Device Size Text, specify	0
Length	40 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00848486028084 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K141989

FDA Product Code

OLO	Orthopedic stereotaxic instrument