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.
| 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 |
| 00763000879587 - ENDOSKELETON® TCS | 2025-09-29 DRIVER 5210-1004 TCS NO 8 HEX STRAIGHT |
| 00763000879600 - ENDOSKELETON® TCS | 2025-09-29 DRIVER 5210-1024 TCS NO 8 HEX U-JOINT |
| 00763000879648 - Endoskeleton™ TCS Interbody System | 2025-09-29 AWL 5210-1062 TCS STRAIGHT FIXED 2MM |
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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