KYPHON Xpander™ Inflatable Bone Tamp

GUDID 00858196001178

TAMP K13A XPANDR INFLAT BONE SIZE 10/3

MEDTRONIC SOFAMOR DANEK, INC.

Inflatable bone tamp
Primary Device ID00858196001178
NIH Device Record Keyd81d7190-ff4d-4629-9457-d0842977ed24
Commercial Distribution Discontinuation2018-04-09
Commercial Distribution StatusNot in Commercial Distribution
Brand NameKYPHON Xpander™ Inflatable Bone Tamp
Version Model NumberK13A
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100858196001178 [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 Number4
Public Version Date2019-01-25
Device Publish Date2016-07-16

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

00613994704009TAMP K08A XPAN INFLAT BONE SIZE 20/3-RB
00613994703996TAMP K09A XPAN INFLAT BONE SIZE 15/3-RB
00613994703989TAMP K13A XPAN INFLAT BONE SIZE 10/3-RB
00643169103078TAMP K13A XPAN INFLAT BONE SIZE 10/3
00643169103061TAMP K09A XPAN INFLAT BONE SIZE 15/3
00643169103054TAMP K08A XPAN INFLAT BONE SIZE 20/3
00858196001178TAMP K13A XPANDR INFLAT BONE SIZE 10/3
00858196001161TAMP K09A XPANDR INFLAT BONE SIZE 15/3
00858196001154TAMP K08A XPANDR INFLAT BONE SIZE 20/3

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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