InflateFX™ Gen II Fracture Management

GUDID 00643169021310

BONE TAMP E103A 10/3 A LA CARTE

MEDTRONIC SOFAMOR DANEK, INC.

Inflatable bone tamp
Primary Device ID00643169021310
NIH Device Record Key007bf860-1790-4840-8cc1-268d7ea2a3d6
Commercial Distribution StatusIn Commercial Distribution
Brand NameInflateFX™ Gen II Fracture Management
Version Model NumberE103A
Company DUNS830350380
Company NameMEDTRONIC SOFAMOR DANEK, INC.
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169021310 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRXARTHROSCOPE

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 Date2016-07-16

On-Brand Devices [InflateFX™ Gen II Fracture Management]

00643169110212TOOLS AND FILLER EL153B LARGE KIT
00643169021310BONE TAMP E103A 10/3 A LA CARTE
00643169348240TOOLKIT IFXG2B SCOOP
00643169157255TOOLS AND FILLER ES103B SMALL KIT
00643169157248TOOLS AND FILLER EL153B LARGE KIT

Trademark Results [InflateFX]

Mark Image

Registration | Serial
Company
Trademark
Application Date
INFLATEFX
INFLATEFX
85441732 4265515 Live/Registered
Kyphon SARL
2011-10-07
INFLATEFX
INFLATEFX
85386999 4258595 Live/Registered
Kyphon SARL
2011-08-02

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