CD Horizon™ Spinal System
GUDID 00763000534592
HOOK 5445122 4.75 NARROW XS SHORT BLADE
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 Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile| Primary Device ID | 00763000534592 |
| NIH Device Record Key | 561dd725-1fb6-47d3-8624-52caf1a94519 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CD Horizon™ Spinal System |
| Version Model Number | 5445122 |
| 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 | false |
| 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 | |
| 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 | 00763000534592 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K091974
FDA Product Code
| NKB | Thoracolumbosacral pedicle screw system |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00763000534592]
Moist Heat or Steam Sterilization
[00763000534592]
Moist Heat or Steam Sterilization
[00763000534592]
Moist Heat or Steam Sterilization
[00763000534592]
Moist Heat or Steam Sterilization
[00763000534592]
Moist Heat or Steam Sterilization
[00763000534592]
Moist Heat or Steam Sterilization
[00763000534592]
Moist Heat or Steam Sterilization
[00763000534592]
Moist Heat or Steam Sterilization
[00763000534592]
Moist Heat or Steam Sterilization
[00763000534592]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-09-06 |
| Device Publish Date | 2021-08-28 |
On-Brand Devices [CD Horizon™ Spinal System]
| 00763000360344 | ROD 9010014636 6.0 TI 13.8MM OFFSET |
| 00763000360337 | ROD 9010014635 6.0 TI 13.5MM OFFSET |
| 00763000360320 | ROD 9010014634 6.0 TI 13.1MM OFFSET |
| 00763000360313 | ROD 9010014633 6.0 TI 12.8MM OFFSET |
| 00763000360306 | ROD 9010014632 6.0 TI 12MM OFFSET |
| 00763000360290 | ROD 9010014631 6.0 TI 11.4MM OFFSET |
| 00763000360283 | ROD 9010014630 5.5 TI 14.2MM OFFSET |
| 00763000360276 | ROD 9010014629 5.5 TI 13.8MM OFFSET |
| 00763000360245 | ROD 9010014626 5.5 TI 12.8MM OFFSET |
| 00763000360191 | ROD 9010014621 6.0 CCM+ 13.5MM OFFSET |
| 00763000360153 | ROD 9010014617 6.0 CCM+ 11.4MM OFFSET |
| 00763000360146 | ROD 9010014616 5.5 CCM+ 14.2MM OFFSET |
| 00763000360139 | ROD 9010014615 5.5 CCM+ 13.8MM OFFSET |
| 00763000360122 | ROD 9010014614 5.5 CCM+ 13.5MM OFFSET |
| 00763000360115 | ROD 9010014613 5.5 CCM+ 13.1MM OFFSET |
| 00763000360108 | ROD 9010014612 5.5 CCM+ 12.8MM OFFSET |
| 00763000360092 | ROD 9010014611 5.5 CCM+ 12MM OFFSET |
| 00763000360085 | ROD 9010014610 5.5 CCM+ 11.4MM OFFSET |
| 00763000360351 | ROD 9010014637 6.0 TI 14.2MM OFFSET |
| 00763000360269 | ROD 9010014628 5.5 TI 13.5MM OFFSET |
| 00763000360252 | ROD 9010014627 5.5 TI 13.1MM OFFSET |
| 00763000360238 | ROD 9010014625 5.5 TI 12MM OFFSET |
| 00763000360221 | ROD 9010014624 5.5 TI 11.4MM OFFSET |
| 00763000360214 | ROD 9010014623 6.0 CCM+ 14.2MM OFFSET |
| 00763000360207 | ROD 9010014622 6.0 CCM+ 13.8MM OFFSET |
| 00763000360184 | ROD 9010014620 6.0 CCM+ 13.1MM OFFSET |
| 00763000360177 | ROD 9010014619 6.0 CCM+ 12.8MM OFFSET |
| 00763000360160 | ROD 9010014618 6.0 CCM+ 12MM OFFSET |
| 00763000534592 | HOOK 5445122 4.75 NARROW XS SHORT BLADE |
| 00763000534578 | HOOK 5445101 4.75 PEDICLE XS SHORT BLADE |
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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