111655

GUDID 00848486017323

VARIABLE ANGLE FIXATION SCREW

MAKO SURGICAL CORP.

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Primary Device ID00848486017323
NIH Device Record Keyebab6f5c-ca9e-4abd-ac13-e1fbe61a9453
Commercial Distribution StatusIn Commercial Distribution
Version Model Number111655
Catalog Number111655
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100848486017323 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OLOOrthopedic stereotaxic instrument

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

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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