206967

GUDID 00848486022167

HIP END EFFECTOR VARIABLE ANGLE

MAKO SURGICAL CORP.

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Primary Device ID00848486022167
NIH Device Record Key11f263e3-bef3-40eb-bec3-a9263b03bd96
Commercial Distribution StatusIn Commercial Distribution
Version Model Number206967
Catalog Number206967
Company DUNS175239677
Company NameMAKO SURGICAL CORP.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100848486022167 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OLOOrthopedic stereotaxic instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00848486022167]

Moist Heat or Steam Sterilization


[00848486022167]

Moist Heat or Steam Sterilization


[00848486022167]

Moist Heat or Steam Sterilization


[00848486022167]

Moist Heat or Steam Sterilization


[00848486022167]

Moist Heat or Steam Sterilization


[00848486022167]

Moist Heat or Steam Sterilization


[00848486022167]

Moist Heat or Steam Sterilization


[00848486022167]

Moist Heat or Steam Sterilization


[00848486022167]

Moist Heat or Steam Sterilization


[00848486022167]

Moist Heat or Steam Sterilization


[00848486022167]

Moist Heat or Steam Sterilization


[00848486022167]

Moist Heat or Steam Sterilization


[00848486022167]

Moist Heat or Steam Sterilization


[00848486022167]

Moist Heat or Steam Sterilization


[00848486022167]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

Devices Manufactured by MAKO SURGICAL CORP.

07613327599985 - Mako2023-07-31
07613327600001 - Mako2023-07-31
07613327600063 - Mako2023-07-31
07613327600070 - Mako2023-07-31
07613327601008 - Mako2023-07-31
00848486022747 - Calibration End Effector Inverted2022-10-13 Calibration End Effector Inverted
07613327395341 - Mako2021-04-07
07613327395280 - NA2020-12-23

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