CD Horizon™ ModuLeX™ Spinal System
GUDID 00763000436124
SHANK 55900207545 7.5 X 45 ATS THREAD
MEDTRONIC SOFAMOR DANEK, INC.
Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile| Primary Device ID | 00763000436124 |
| NIH Device Record Key | 0d572563-1859-4031-8163-caa409d289c5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CD Horizon™ ModuLeX™ Spinal System |
| Version Model Number | 55900207545 |
| 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 |
Customer Support Contacts
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000436124 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K210637
FDA Product Code
| NKB | Thoracolumbosacral pedicle screw system |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00763000436124]
Moist Heat or Steam Sterilization
[00763000436124]
Moist Heat or Steam Sterilization
[00763000436124]
Moist Heat or Steam Sterilization
[00763000436124]
Moist Heat or Steam Sterilization
[00763000436124]
Moist Heat or Steam Sterilization
[00763000436124]
Moist Heat or Steam Sterilization
[00763000436124]
Moist Heat or Steam Sterilization
[00763000436124]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-08-23 |
| Device Publish Date | 2021-08-13 |
On-Brand Devices [CD Horizon™ ModuLeX™ Spinal System]
| 00763000435769 | SET SCREW PK 559200014 STERILE B/OFF 2PK |
| 00763000435752 | HEAD PK 559200013 SINGLE HEAD 4PK |
| 00763000435745 | HEAD PK 559200012 SINGLE HEAD 2PK |
| 00763000435721 | SET SCREW PK 559200010 STERILE B/OFF 4PK |
| 00763000435707 | MAS/SET SCREW PK 559200008 STERILE 4PK |
| 00763000435691 | MAS/SET SCREW PK 559200007 STERILE 2PK |
| 00763000465599 | CORTICL CONN G559300156 TOP-SIDE 5.5/6.0 |
| 00763000465582 | CORTICL CONN G559300145 TOP-SIDE 4.5/5.0 |
| 00763000465575 | ROD 1552000025 5.5MM STRT ROD 25MM TI NS |
| 00763000457860 | SLEEVE 5598032 DEPTH STOP SLEEVE |
| 00763000436162 | SHANK 55900207565 7.5 X 65 ATS THREAD |
| 00763000436155 | SHANK 55900207560 7.5 X 60 ATS THREAD |
| 00763000436148 | SHANK 55900207555 7.5 X 55 ATS THREAD |
| 00763000436131 | SHANK 55900207550 7.5 X 50 ATS THREAD |
| 00763000436124 | SHANK 55900207545 7.5 X 45 ATS THREAD |
| 00763000436117 | SHANK 55900207540 7.5 X 40 ATS THREAD |
| 00763000436100 | SHANK 55900206560 6.5 X 60 ATS THREAD |
| 00763000436094 | SHANK 55900206555 6.5 X 55 ATS THREAD |
| 00763000436087 | SHANK 55900206550 6.5 X 50 ATS THREAD |
| 00763000436070 | SHANK 55900206545 6.5 X 45 ATS THREAD |
| 00763000436063 | SHANK 55900206540 6.5 X 40 ATS THREAD |
| 00763000436056 | SHANK 55900206535 6.5 X 35 ATS THREAD |
| 00763000436049 | SHANK 55900206530 6.5 X 30 ATS THREAD |
| 00763000436032 | SHANK 55900205550 5.5 X 50 ATS THREAD |
| 00763000436025 | SHANK 55900205545 5.5 X 45 ATS THREAD |
| 00763000436018 | SHANK 55900205540 5.5 X 40 ATS THREAD |
| 00763000436001 | SHANK 55900205535 5.5 X 35 ATS THREAD |
| 00763000435998 | SHANK 55900205530 5.5 X 30 ATS THREAD |
| 00763000435981 | SHANK 55900204540 4.5 X 40 ATS THREAD |
| 00763000435974 | SHANK 55900204535 4.5 X 35 ATS THREAD |
| 00763000435967 | SHANK 55900204530 4.5 X 30 ATS THREAD |
| 00763000435844 | TAP NAV5591075 7.5 NAV CORTICAL TAP |
| 00763000435837 | TAP NAV5591065 6.5 NAV CORTICAL TAP |
| 00763000435820 | TAP NAV5591055 5.5 NAV CORTICAL TAP |
| 00763000435813 | TAP NAV5591045 4.5 NAV CORTICAL TAP |
| 00763000435806 | TAP 5591075 7.5 MANUAL CORTICAL TAP |
| 00763000435790 | TAP 5591065 6.5 MANUAL CORTICAL TAP |
| 00763000435783 | TAP 5591055 5.5 MANUAL CORTICAL TAP |
| 00763000435776 | TAP 5591045 4.5 MANUAL CORTICAL TAP |
| 00763000435738 | HEAD 559200011 SINGLE HEAD |
| 00763000435714 | SET SCREW 559200009 STERILE BREAK OFF |
| 00763000435684 | MAS/SET SCREW 559200006 STERILE MAS/SS |
| 00763000435660 | SHANK 55900107565 7.5 X 65 CORTICAL |
| 00763000435653 | SHANK 55900107560 7.5 X 60 CORTICAL |
| 00763000435646 | SHANK 55900107555 7.5 X 55 CORTICAL |
| 00763000435639 | SHANK 55900107550 7.5 X 50 CORTICAL |
| 00763000435622 | SHANK 55900107545 7.5 X 45 CORTICAL |
| 00763000435615 | SHANK 55900107540 7.5 X 40 CORTICAL |
| 00763000435608 | SHANK 55900106560 6.5 X 60 CORTICAL |
| 00763000435592 | SHANK 55900106555 6.5 X 55 CORTICAL |
Trademark Results [CD Horizon]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CD HORIZON 75079759 2108361 Live/Registered |
WARSAW ORTHOPEDIC, INC. 1996-03-28 |
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