| Primary Device ID | 00763000312015 |
| NIH Device Record Key | d1fea627-f431-44d4-84e9-765e611875d9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | KYPHON® Express™ II Inflatable Bone Tamp |
| Version Model Number | KE102 |
| 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 | false |
| 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 | |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool (at max. 25°C / 77°F), dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool (at max. 25°C / 77°F), dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool (at max. 25°C / 77°F), dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool (at max. 25°C / 77°F), dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool (at max. 25°C / 77°F), dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool (at max. 25°C / 77°F), dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool (at max. 25°C / 77°F), dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool (at max. 25°C / 77°F), dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool (at max. 25°C / 77°F), dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool (at max. 25°C / 77°F), dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool (at max. 25°C / 77°F), dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool (at max. 25°C / 77°F), dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool (at max. 25°C / 77°F), dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool (at max. 25°C / 77°F), dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool (at max. 25°C / 77°F), dry place |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000312015 [Primary] |
| HXG | TAMP |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-10-05 |
| Device Publish Date | 2020-09-25 |
| 00763000273804 - n/a | 2025-10-06 SCREWDRIVER 3606201 TORQUE LIMIT SHAFT |
| 00763000875282 - SHILLA™ Growth Guidance System | 2025-10-06 SCREW 7675430 5.5 SHILLA MAS CANN 4.5X30 |
| 00763000884956 - n/a | 2025-10-06 LOCK SCREW DRIVER 7080930 TRI-FLAT |
| 00885074240695 - n/a | 2025-09-30 ACCESSORIES 3299003 GRAFT TAMP |
| 00199150026029 - Medtronic Reusable Instruments | 2025-09-29 COMPRESSOR X0525001 RACK AND PINION |
| 00763000684044 - Medtronic Reusable Instruments | 2025-09-29 INSTRUMENT 950-146 RULER |
| 00763000856700 - VERTE-STACK® Spinal System | 2025-09-29 STRUT 6242064 ANATOMIC 16X14X24MM |
| 00763000879563 - ENDOSKELETON® TCS | 2025-09-29 HANDLE 5210-1016 TCS RATCHETING HANDLE |
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 |