KYPHON Xpander™ II Inflatable Bone Tamp

GUDID 00643169093652

BONE TAMP KX153 15/3 XPANDER II IBT

MEDTRONIC SOFAMOR DANEK, INC.

Inflatable bone tamp
Primary Device ID00643169093652
NIH Device Record Key312907b8-e4f0-49a9-95b7-076b872e946e
Commercial Distribution StatusIn Commercial Distribution
Brand NameKYPHON Xpander™ II Inflatable Bone Tamp
Version Model NumberKX153
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
GS100643169093652 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HXGTAMP

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 Date2016-04-02

On-Brand Devices [KYPHON Xpander™ II Inflatable Bone Tamp]

00643169093676BONE TAMP KX203 20/3 XPANDER II IBT
00643169093652BONE TAMP KX153 15/3 XPANDER II IBT
00643169093645BONE TAMP KX103-C 10/3 XPANDER II IBT EU
00643169093638BONE TAMP KX103 10/3 XPANDER II IBT

Trademark Results [KYPHON Xpander]

Mark Image

Registration | Serial
Company
Trademark
Application Date
KYPHON XPANDER
KYPHON XPANDER
77406668 3944666 Live/Registered
MEDTRONIC HOLDING COMPANY SARL
2008-02-26

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