207110

GUDID 00848486022211

Guidance Module

MAKO SURGICAL CORP.

Robotic surgical navigation system

Primary Device ID	00848486022211
NIH Device Record Key	1556fb1d-206f-454d-aa87-a82f6ee3e233
Commercial Distribution Status	In Commercial Distribution
Version Model Number	207110
Catalog Number	207110
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	true
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	00848486022211 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K112507

FDA Product Code

OLO	Orthopedic stereotaxic instrument

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[00848486022211]

Moist Heat or Steam Sterilization

[00848486022211]

Moist Heat or Steam Sterilization

[00848486022211]

Moist Heat or Steam Sterilization

[00848486022211]

Moist Heat or Steam Sterilization

[00848486022211]

Moist Heat or Steam Sterilization

[00848486022211]

Moist Heat or Steam Sterilization

[00848486022211]

Moist Heat or Steam Sterilization

[00848486022211]

Moist Heat or Steam Sterilization

[00848486022211]

Moist Heat or Steam Sterilization

[00848486022211]

Moist Heat or Steam Sterilization

[00848486022211]

Moist Heat or Steam Sterilization

[00848486022211]

Moist Heat or Steam Sterilization

[00848486022211]

Moist Heat or Steam Sterilization

[00848486022211]

Moist Heat or Steam Sterilization

[00848486022211]

Moist Heat or Steam Sterilization

[00848486022211]

Moist Heat or Steam Sterilization

[00848486022211]

Moist Heat or Steam Sterilization

[00848486022211]

Moist Heat or Steam Sterilization

[00848486022211]

Moist Heat or Steam Sterilization

[00848486022211]

Moist Heat or Steam Sterilization

[00848486022211]

Moist Heat or Steam Sterilization

[00848486022211]

Moist Heat or Steam Sterilization

[00848486022211]

Moist Heat or Steam Sterilization

[00848486022211]

Moist Heat or Steam Sterilization

[00848486022211]

Moist Heat or Steam Sterilization

[00848486022211]

Moist Heat or Steam Sterilization

[00848486022211]

Moist Heat or Steam Sterilization

[00848486022211]

Moist Heat or Steam Sterilization

[00848486022211]

Moist Heat or Steam Sterilization

[00848486022211]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2018-07-06
Device Publish Date	2016-09-24

Devices Manufactured by MAKO SURGICAL CORP.

07613327627220 - Mako	2024-11-26 MAKO SHOULDER ROUTER
07613327627565 - Mako	2024-11-26 MICS SAGITTAL BLADE, STANDARD
07613327627572 - Mako	2024-11-26 Blade-Narrow
07613327626971 - Mako	2024-11-25 Mako Shoulder Array Kit
07613327627213 - Mako	2024-11-25 Mako Shoulder Burr
07613327625868 - INSTRUMENT	2024-10-14 Spine Pedicle End Effector
07613327625875 - INSTRUMENT	2024-10-14 Spine Pedicle Registration Tool
07613327624304 - NA	2024-09-26 Robotic Arm

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