KYPHON® Xpede™ Bone Cement

GUDID 00643169097803

BONE CEMENT CX01A XPEDE US

MEDTRONIC SOFAMOR DANEK, INC.

Orthopaedic cement, non-medicated 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

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.

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00763000585020 - CD HORIZON® Spinal System2024-03-25 MEDIA BTL GS GL45 250 ML 10/CS
00763000835095 - Medtronic Reusable Instruments2024-03-25 TRIAL EX0223002 12 DEG. LORDOTIC LG 8MM
00763000835118 - Medtronic Reusable Instruments2024-03-25 TRIAL EX0223004 12 DEG. LORDOTIC LG 10MM
00763000835132 - Medtronic Reusable Instruments2024-03-25 TRIAL EX0223006 12 DEG. LORDOTIC LG 12MM
00763000835156 - Medtronic Reusable Instruments2024-03-25 TRIAL EX0223008 12 DEG. LORDOTIC LG 14MM
00763000835170 - Medtronic Reusable Instruments2024-03-25 TRIAL EX0223010 12 DEG. LORDOTIC LG 16MM
00763000516543 - Anteralign Spinal System with Titan nanoLock Surface technology2024-03-15 BONE SCREW 4675025 LS 5.0X25MMT

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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