RESTORIS, RIO 207084

GUDID 00848486022204

REAMER HANDLE, STRAIGHT

MAKO SURGICAL CORP.

Orthopaedic reamer handle Surgical power tool system handpiece, reaming, pneumatic Surgical power tool system handpiece, reaming, pneumatic Surgical power tool system handpiece, reaming, pneumatic Surgical power tool system handpiece, reaming, pneumatic Surgical power tool system handpiece, reaming, pneumatic

Primary Device ID	00848486022204
NIH Device Record Key	ea3a1697-60f4-47c3-b0af-8369492fb1e8
Commercial Distribution Status	In Commercial Distribution
Brand Name	RESTORIS, RIO
Version Model Number	207084
Catalog Number	207084
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 Identifiers

Device Issuing Agency	Device ID
GS1	00848486022204 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K121064

FDA Product Code

OLO	Orthopedic stereotaxic instrument