Primary Device ID | 00643169097803 |
NIH Device Record Key | bd579d0a-95a0-4611-bfd6-760e29ae1a94 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | KYPHON® Xpede™ Bone Cement |
Version Model Number | CX01A |
Company DUNS | 830350380 |
Company Name | MEDTRONIC SOFAMOR DANEK, INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com | |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com | |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com | |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com | |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com | |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com | |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com | |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com | |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com | |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com | |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00643169097803 [Primary] |
NDN | CEMENT, BONE, VERTEBROPLASTY |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2015-09-01 |
00643169731059 - Medtronic Transportation/Sterilization Cassette | 2025-04-28 TRAY 7068060T IMPLANT INSTRUMENT 5.5/6.0 |
00721902766138 - MSB General Instruments | 2025-04-28 INSTRUMENT 6276010 FORK HAMMER |
00763000662882 - ZEVO™ Anterior Cervical Plate System | 2025-04-28 SCREW 7713519 ZEVO VAR SD 3.5MM X 19MM |
00885074371191 - MSB General Instruments | 2025-04-28 BLOCK 6279005 PSR LOADING |
00885074515700 - CD HORIZON® Spinal System | 2025-04-28 HOOK, PEDICLE, MD, TI |
00763000663421 - ZEVO™ Anterior Cervical Plate System | 2025-04-25 PLATE 3001023 ZEVO 23MM 1 LVL |
00763000848583 - CD Horizon™ ModuLeX™ Spinal System | 2025-04-25 UAS/SS 559200095 5.5 TI VOYAGER 4 PK |
00763000787820 - CD HORIZON® Spinal System | 2025-04-22 ROD 8672045 SEXTANT 45MM TI |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() KYPHON 77920581 3837842 Dead/Cancelled |
Kyphon SARL 2010-01-26 |
![]() KYPHON 77145293 3380538 Live/Registered |
MEDTRONIC HOLDING COMPANY SARL 2007-03-30 |
![]() KYPHON 77145286 3380537 Dead/Cancelled |
MEDTRONIC HOLDING COMPANY SARL 2007-03-30 |
![]() KYPHON 76124590 2509449 Live/Registered |
MEDTRONIC HOLDING COMPANY SARL 2000-09-07 |
![]() KYPHON 75792575 2436526 Live/Registered |
MEDTRONIC HOLDING COMPANY SARL 1999-09-03 |