CD HORIZON® Spinal System
GUDID 00613994234735
SET SCREW 7220950 PERC PEEK
MEDTRONIC SOFAMOR DANEK, INC.
Bone-screw internal spinal fixation system, non-sterile| Primary Device ID | 00613994234735 |
| NIH Device Record Key | b3190abf-5652-431d-b046-fcc5399a2c93 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CD HORIZON® Spinal System |
| Version Model Number | 7220950 |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00613994234735 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K061915
FDA Product Code
| NQP | POSTERIOR METAL/POLYMER SPINAL SYSTEM, FUSION |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
[00613994234735]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-06-11 |
| Device Publish Date | 2015-08-21 |
Devices Manufactured by MEDTRONIC SOFAMOR DANEK, INC.
| 00643169465916 - Medtronic Reusable Instruments | 2024-12-30 TAP X1013176 4.5MM SOLID |
| 00681490520089 - n/a | 2024-12-30 INSTRUMENT 8756412 DISTRACTOR PIN 12MM |
| 20763000710525 - CD Horizon™ ModuLeX™ Spinal System | 2024-12-23 DRMAS 559200101 HEAD W/2 SET SCREWS |
| 20763000710532 - CD Horizon™ ModuLeX™ Spinal System | 2024-12-23 RDRMAS 559200102 HEAD W/2 SET SCREWS |
| 00763000857172 - VERTE-STACK® Spinal System | 2024-12-16 SPACER 6277441 CORNERSTONE PSR 4X14X11MM |
| 00763000857387 - VERTE-STACK® Spinal System | 2024-12-16 SPACER 6277006 PSR STRUT 6 X 14 X 11MM |
| 00763000868475 - CORNERSTONE® PSR Cervical Fusion System | 2024-12-16 IMPLANT 6284641 PEEK CRV 14X11X6MM |
| 00763000878818 - NA | 2024-12-16 INSTRUMENT 803-043 GUIDEWIRE |
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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