700000341417

GUDID 07613327468304

Mako THA Array Kit Upper Tray

MAKO SURGICAL CORP.

Instrument tray
Primary Device ID07613327468304
NIH Device Record Key02dade29-c4f6-42b4-bdb4-3fe94e4917d3
Commercial Distribution StatusIn Commercial Distribution
Version Model Number700000341417
Catalog Number700000341417
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
GS107613327468304 [Primary]

FDA Product Code

FSMTRAY, SURGICAL, INSTRUMENT

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07613327468304]

Moist Heat or Steam Sterilization


[07613327468304]

Moist Heat or Steam Sterilization


[07613327468304]

Moist Heat or Steam Sterilization


[07613327468304]

Moist Heat or Steam Sterilization


[07613327468304]

Moist Heat or Steam Sterilization


[07613327468304]

Moist Heat or Steam Sterilization


[07613327468304]

Moist Heat or Steam Sterilization


[07613327468304]

Moist Heat or Steam Sterilization


[07613327468304]

Moist Heat or Steam Sterilization


[07613327468304]

Moist Heat or Steam Sterilization


[07613327468304]

Moist Heat or Steam Sterilization


[07613327468304]

Moist Heat or Steam Sterilization


[07613327468304]

Moist Heat or Steam Sterilization


[07613327468304]

Moist Heat or Steam Sterilization


[07613327468304]

Moist Heat or Steam Sterilization


[07613327468304]

Moist Heat or Steam Sterilization


[07613327468304]

Moist Heat or Steam Sterilization


[07613327468304]

Moist Heat or Steam Sterilization


[07613327468304]

Moist Heat or Steam Sterilization


[07613327468304]

Moist Heat or Steam Sterilization


[07613327468304]

Moist Heat or Steam Sterilization


[07613327468304]

Moist Heat or Steam Sterilization


[07613327468304]

Moist Heat or Steam Sterilization


[07613327468304]

Moist Heat or Steam Sterilization


[07613327468304]

Moist Heat or Steam Sterilization


[07613327468304]

Moist Heat or Steam Sterilization


[07613327468304]

Moist Heat or Steam Sterilization


[07613327468304]

Moist Heat or Steam Sterilization


[07613327468304]

Moist Heat or Steam Sterilization


[07613327468304]

Moist Heat or Steam Sterilization


[07613327468304]

Moist Heat or Steam Sterilization


[07613327468304]

Moist Heat or Steam Sterilization


[07613327468304]

Moist Heat or Steam Sterilization


[07613327468304]

Moist Heat or Steam Sterilization


[07613327468304]

Moist Heat or Steam Sterilization


[07613327468304]

Moist Heat or Steam Sterilization


[07613327468304]

Moist Heat or Steam Sterilization


[07613327468304]

Moist Heat or Steam Sterilization


[07613327468304]

Moist Heat or Steam Sterilization


[07613327468304]

Moist Heat or Steam Sterilization


[07613327468304]

Moist Heat or Steam Sterilization


[07613327468304]

Moist Heat or Steam Sterilization


[07613327468304]

Moist Heat or Steam Sterilization


[07613327468304]

Moist Heat or Steam Sterilization


[07613327468304]

Moist Heat or Steam Sterilization


[07613327468304]

Moist Heat or Steam Sterilization


[07613327468304]

Moist Heat or Steam Sterilization


[07613327468304]

Moist Heat or Steam Sterilization


[07613327468304]

Moist Heat or Steam Sterilization


[07613327468304]

Moist Heat or Steam Sterilization


[07613327468304]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-09
Device Publish Date2020-02-28

Devices Manufactured by MAKO SURGICAL CORP.

07613327627220 - Mako2024-11-26 MAKO SHOULDER ROUTER
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

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.