160245

GUDID 00848486003142

FEMORAL ARRAY EXTENDED POST

MAKO SURGICAL CORP.

Orthopaedic prosthesis implantation instrument, reusable

Primary Device ID	00848486003142
NIH Device Record Key	e147e603-c0a4-4c90-b370-6e6ad8f81d71
Commercial Distribution Status	In Commercial Distribution
Version Model Number	160245
Catalog Number	160245
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	00848486003142 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K121064

FDA Product Code

OLO	Orthopedic stereotaxic instrument

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[00848486003142]

Moist Heat or Steam Sterilization

[00848486003142]

Moist Heat or Steam Sterilization

[00848486003142]

Moist Heat or Steam Sterilization

[00848486003142]

Moist Heat or Steam Sterilization

[00848486003142]

Moist Heat or Steam Sterilization

[00848486003142]

Moist Heat or Steam Sterilization

[00848486003142]

Moist Heat or Steam Sterilization

[00848486003142]

Moist Heat or Steam Sterilization

[00848486003142]

Moist Heat or Steam Sterilization

[00848486003142]

Moist Heat or Steam Sterilization

[00848486003142]

Moist Heat or Steam Sterilization

[00848486003142]

Moist Heat or Steam Sterilization

[00848486003142]

Moist Heat or Steam Sterilization

[00848486003142]

Moist Heat or Steam Sterilization

[00848486003142]

Moist Heat or Steam Sterilization

[00848486003142]

Moist Heat or Steam Sterilization

[00848486003142]

Moist Heat or Steam Sterilization

[00848486003142]

Moist Heat or Steam Sterilization

[00848486003142]

Moist Heat or Steam Sterilization

[00848486003142]

Moist Heat or Steam Sterilization

[00848486003142]

Moist Heat or Steam Sterilization

[00848486003142]

Moist Heat or Steam Sterilization

[00848486003142]

Moist Heat or Steam Sterilization

[00848486003142]

Moist Heat or Steam Sterilization

[00848486003142]

Moist Heat or Steam Sterilization

[00848486003142]

Moist Heat or Steam Sterilization

[00848486003142]

Moist Heat or Steam Sterilization

[00848486003142]

Moist Heat or Steam Sterilization

[00848486003142]

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

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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

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