ACCOLADE II 210433-3230

GUDID 00848486028107

132¿ 30mm NECK TRIAL

MAKO SURGICAL CORP.

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Primary Device ID	00848486028107
NIH Device Record Key	27d648d9-3f2a-4a61-9d1c-0507a0f79cb1
Commercial Distribution Status	In Commercial Distribution
Brand Name	ACCOLADE II
Version Model Number	210433-3230
Catalog Number	210433-3230
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

Device Size Text, specify	0
Device Size Text, specify	0
Length	30 Millimeter
Device Size Text, specify	0
Length	30 Millimeter
Device Size Text, specify	0
Length	30 Millimeter
Device Size Text, specify	0
Length	30 Millimeter
Device Size Text, specify	0
Length	30 Millimeter
Device Size Text, specify	0
Length	30 Millimeter
Device Size Text, specify	0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00848486028107 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K141989

FDA Product Code

OLO	Orthopedic stereotaxic instrument