KYPHON® Xpede™ Bone Cement

GUDID 00643169097803

BONE CEMENT CX01A XPEDE US

MEDTRONIC SOFAMOR DANEK, INC.

Orthopaedic cement, non-medicated
Primary Device ID00643169097803
NIH Device Record Keybd579d0a-95a0-4611-bfd6-760e29ae1a94
Commercial Distribution StatusIn Commercial Distribution
Brand NameKYPHON® Xpede™ Bone Cement
Version Model NumberCX01A
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169097803 [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 Date2015-09-01

Devices Manufactured by MEDTRONIC SOFAMOR DANEK, INC.

00643169731059 - Medtronic Transportation/Sterilization Cassette2025-04-28 TRAY 7068060T IMPLANT INSTRUMENT 5.5/6.0
00721902766138 - MSB General Instruments2025-04-28 INSTRUMENT 6276010 FORK HAMMER
00763000662882 - ZEVO™ Anterior Cervical Plate System2025-04-28 SCREW 7713519 ZEVO VAR SD 3.5MM X 19MM
00885074371191 - MSB General Instruments2025-04-28 BLOCK 6279005 PSR LOADING
00885074515700 - CD HORIZON® Spinal System2025-04-28 HOOK, PEDICLE, MD, TI
00763000663421 - ZEVO™ Anterior Cervical Plate System2025-04-25 PLATE 3001023 ZEVO 23MM 1 LVL
00763000848583 - CD Horizon™ ModuLeX™ Spinal System2025-04-25 UAS/SS 559200095 5.5 TI VOYAGER 4 PK
00763000787820 - CD HORIZON® Spinal System2025-04-22 ROD 8672045 SEXTANT 45MM TI

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

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.