CD Horizon™ Spinal System
GUDID 00763000360351
ROD 9010014637 6.0 TI 14.2MM OFFSET
MEDTRONIC SOFAMOR DANEK, INC.
Bone-screw internal spinal fixation system, non-sterile| Primary Device ID | 00763000360351 |
| NIH Device Record Key | 2f12bda3-2303-4feb-858f-ea78ddb7f045 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CD Horizon™ Spinal System |
| Version Model Number | 9010014637 |
| 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
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000360351 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K113174
FDA Product Code
| NKB | Thoracolumbosacral pedicle screw system |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00763000360351]
Moist Heat or Steam Sterilization
[00763000360351]
Moist Heat or Steam Sterilization
[00763000360351]
Moist Heat or Steam Sterilization
[00763000360351]
Moist Heat or Steam Sterilization
[00763000360351]
Moist Heat or Steam Sterilization
[00763000360351]
Moist Heat or Steam Sterilization
[00763000360351]
Moist Heat or Steam Sterilization
[00763000360351]
Moist Heat or Steam Sterilization
[00763000360351]
Moist Heat or Steam Sterilization
[00763000360351]
Moist Heat or Steam Sterilization
[00763000360351]
Moist Heat or Steam Sterilization
[00763000360351]
Moist Heat or Steam Sterilization
[00763000360351]
Moist Heat or Steam Sterilization
[00763000360351]
Moist Heat or Steam Sterilization
[00763000360351]
Moist Heat or Steam Sterilization
[00763000360351]
Moist Heat or Steam Sterilization
[00763000360351]
Moist Heat or Steam Sterilization
[00763000360351]
Moist Heat or Steam Sterilization
[00763000360351]
Moist Heat or Steam Sterilization
[00763000360351]
Moist Heat or Steam Sterilization
[00763000360351]
Moist Heat or Steam Sterilization
[00763000360351]
Moist Heat or Steam Sterilization
[00763000360351]
Moist Heat or Steam Sterilization
[00763000360351]
Moist Heat or Steam Sterilization
[00763000360351]
Moist Heat or Steam Sterilization
[00763000360351]
Moist Heat or Steam Sterilization
[00763000360351]
Moist Heat or Steam Sterilization
[00763000360351]
Moist Heat or Steam Sterilization
[00763000360351]
Moist Heat or Steam Sterilization
[00763000360351]
Moist Heat or Steam Sterilization
[00763000360351]
Moist Heat or Steam Sterilization
[00763000360351]
Moist Heat or Steam Sterilization
[00763000360351]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-01-05 |
| Device Publish Date | 2020-12-28 |
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 |
| 00763000883416 | TRAY 5598946 60MM REDUX DEGEN INSTRUMENT |
| 00763000867713 | TRAY RBT5598949 MDX MZR PREASSEM DRV15.5 |
| 00763000867706 | TRAY RBT5598948 MDX MZR RATCHET 15.5 INS |
| 00763000867690 | TRAY RBT5598947 MDX MZR RATCHET 10.5 INS |
| 00763000845162 | DRIVER RBT085434 RG CLOSED LONG |
| 00763000845155 | DRIVER RBT085334 RG CLOSED SHORT |
| 00763000845124 | DRIVER RBT085432 RG REDUX PLUS LONG |
| 00763000845117 | DRIVER RBT085332 RG REDUX PLUS SHORT |
| 00763000845100 | DRIVER RBT085431 RG REDUX/VOYAGER LONG |
| 00763000845094 | DRIVER RBT085331 RG REDUX/VOYAGER SHORT |
| 00763000845087 | DRIVER RBT085430 RG STANDARD LONG |
| 00763000845070 | DRIVER RBT085330 RG STANDARD SHORT |
| 00763000844981 | SHANK DRIVER RBT085810 RG RATCH LNG 15.5 |
| 00763000844974 | SHANK DRIVER RBT085710 RG RATCH SHRT15.5 |
| 00763000844967 | SHANK DRIVER RBT075810 RG RATCH LNG 10.5 |
| 00763000844950 | SHANK DRIVER RBT075710 RG RATCH SHRT10.5 |
| 00763000830052 | TRAY 5598933 MODULEX LONG CLOSED REDUCER |
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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