150451

GUDID 00848486029616

Spacer Paddle Caddy, MAKOplasty¿ PKA Array Kit

MAKO SURGICAL CORP.

Instrument tray
Primary Device ID00848486029616
NIH Device Record Key19d1aec5-e9db-403e-972f-bf5ddeab62c2
Commercial Distribution StatusIn Commercial Distribution
Version Model Number150451
Catalog Number150451
Company DUNS175239677
Company NameMAKO SURGICAL CORP.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
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
GS100848486029616 [Primary]

FDA Product Code

FSMTRAY, SURGICAL, INSTRUMENT

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00848486029616]

Moist Heat or Steam Sterilization


[00848486029616]

Moist Heat or Steam Sterilization


[00848486029616]

Moist Heat or Steam Sterilization


[00848486029616]

Moist Heat or Steam Sterilization


[00848486029616]

Moist Heat or Steam Sterilization


[00848486029616]

Moist Heat or Steam Sterilization


[00848486029616]

Moist Heat or Steam Sterilization


[00848486029616]

Moist Heat or Steam Sterilization


[00848486029616]

Moist Heat or Steam Sterilization


[00848486029616]

Moist Heat or Steam Sterilization


[00848486029616]

Moist Heat or Steam Sterilization


[00848486029616]

Moist Heat or Steam Sterilization


[00848486029616]

Moist Heat or Steam Sterilization


[00848486029616]

Moist Heat or Steam Sterilization


[00848486029616]

Moist Heat or Steam Sterilization


[00848486029616]

Moist Heat or Steam Sterilization


[00848486029616]

Moist Heat or Steam Sterilization


[00848486029616]

Moist Heat or Steam Sterilization


[00848486029616]

Moist Heat or Steam Sterilization


[00848486029616]

Moist Heat or Steam Sterilization


[00848486029616]

Moist Heat or Steam Sterilization


[00848486029616]

Moist Heat or Steam Sterilization


[00848486029616]

Moist Heat or Steam Sterilization


[00848486029616]

Moist Heat or Steam Sterilization


[00848486029616]

Moist Heat or Steam Sterilization


[00848486029616]

Moist Heat or Steam Sterilization


[00848486029616]

Moist Heat or Steam Sterilization


[00848486029616]

Moist Heat or Steam Sterilization


[00848486029616]

Moist Heat or Steam Sterilization


[00848486029616]

Moist Heat or Steam Sterilization


[00848486029616]

Moist Heat or Steam Sterilization


[00848486029616]

Moist Heat or Steam Sterilization


[00848486029616]

Moist Heat or Steam Sterilization


[00848486029616]

Moist Heat or Steam Sterilization


[00848486029616]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-08-09
Device Publish Date2016-09-24

Devices Manufactured by MAKO SURGICAL CORP.

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07613327627565 - Mako2024-11-26 MICS SAGITTAL BLADE, STANDARD
07613327627572 - Mako2024-11-26 Blade-Narrow
07613327626971 - Mako2024-11-25 Mako Shoulder Array Kit
07613327627213 - Mako2024-11-25 Mako Shoulder Burr
07613327625868 - INSTRUMENT2024-10-14 Spine Pedicle End Effector
07613327625875 - INSTRUMENT2024-10-14 Spine Pedicle Registration Tool
07613327624304 - NA2024-09-26 Robotic Arm

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