KYPHON® ELEMENT™

GUDID 00763000025823

INFLATABLE BONE TAMP KR153 15MM VALUEIBT

MEDTRONIC SOFAMOR DANEK, INC.

Inflatable bone tamp
Primary Device ID00763000025823
NIH Device Record Keyb9251d77-c970-4237-9591-966610889f14
Commercial Distribution StatusIn Commercial Distribution
Brand NameKYPHON® ELEMENT™
Version Model NumberKR153
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 Perscriptiontrue
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
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Device Dimensions

Outer Diameter3 Millimeter
Length15 Millimeter
Outer Diameter3 Millimeter
Length15 Millimeter
Outer Diameter3 Millimeter
Length15 Millimeter
Outer Diameter3 Millimeter
Length15 Millimeter
Outer Diameter3 Millimeter
Length15 Millimeter
Outer Diameter3 Millimeter
Length15 Millimeter
Outer Diameter3 Millimeter
Length15 Millimeter
Outer Diameter3 Millimeter
Length15 Millimeter
Outer Diameter3 Millimeter
Length15 Millimeter
Outer Diameter3 Millimeter
Length15 Millimeter
Outer Diameter3 Millimeter
Length15 Millimeter
Outer Diameter3 Millimeter
Length15 Millimeter
Outer Diameter3 Millimeter
Length15 Millimeter
Outer Diameter3 Millimeter
Length15 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000025823 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HXGTAMP

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-23
Device Publish Date2020-10-15

On-Brand Devices [KYPHON® ELEMENT™]

00643169582217INFLATABLE BONE TAMP KR153 15MM VALUEIBT
00763000025823INFLATABLE BONE TAMP KR153 15MM VALUEIBT

Trademark Results [KYPHON]

Mark Image

Registration | Serial
Company
Trademark
Application Date
KYPHON
KYPHON
77920581 3837842 Dead/Cancelled
Kyphon SARL
2010-01-26
KYPHON
KYPHON
77145293 3380538 Live/Registered
MEDTRONIC HOLDING COMPANY SARL
2007-03-30
KYPHON
KYPHON
77145286 3380537 Dead/Cancelled
MEDTRONIC HOLDING COMPANY SARL
2007-03-30
KYPHON
KYPHON
76124590 2509449 Live/Registered
MEDTRONIC HOLDING COMPANY SARL
2000-09-07
KYPHON
KYPHON
75792575 2436526 Live/Registered
MEDTRONIC HOLDING COMPANY SARL
1999-09-03

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