KYPHON® HV-R® Bone Cement

GUDID 00613994583215

CEMENT C01A KYPHX HV-R BONE CEMENT EN

MEDTRONIC SOFAMOR DANEK, INC.

Orthopaedic cement, non-medicated
Primary Device ID00613994583215
NIH Device Record Key879586bf-7601-4a00-8f92-efb38610acf7
Commercial Distribution StatusIn Commercial Distribution
Brand NameKYPHON® HV-R® Bone Cement
Version Model NumberC01A
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100613994583215 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NDNCEMENT, BONE, VERTEBROPLASTY

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 Date2015-09-02

On-Brand Devices [KYPHON® HV-R® Bone Cement]

00613994745606BONE CEMENT C01A HV-R CAN
00613994745590BONE CEMENT C01A HV-R US
00613994583215CEMENT C01A KYPHX HV-R BONE CEMENT EN
00643169097865BONE CEMENT C01A HV-R US

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.