CD HORIZON® SOLERA® VOYAGER™ Spinal System
GUDID 00643169544994
SCREW X0114293 CCM 4.75 XTAB 10.0X95
MEDTRONIC SOFAMOR DANEK, INC.
Bone-screw internal spinal fixation system, non-sterile| Primary Device ID | 00643169544994 |
| NIH Device Record Key | 8bf87c77-56a7-4df3-bdfa-c8474bab20f9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CD HORIZON® SOLERA® VOYAGER™ Spinal System |
| Version Model Number | X0114293 |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643169544994 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K143375
FDA Product Code
| MNH | Orthosis, spondylolisthesis spinal fixation |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00643169544994]
Moist Heat or Steam Sterilization
[00643169544994]
Moist Heat or Steam Sterilization
[00643169544994]
Moist Heat or Steam Sterilization
[00643169544994]
Moist Heat or Steam Sterilization
[00643169544994]
Moist Heat or Steam Sterilization
[00643169544994]
Moist Heat or Steam Sterilization
[00643169544994]
Moist Heat or Steam Sterilization
[00643169544994]
Moist Heat or Steam Sterilization
[00643169544994]
Moist Heat or Steam Sterilization
[00643169544994]
Moist Heat or Steam Sterilization
[00643169544994]
Moist Heat or Steam Sterilization
[00643169544994]
Moist Heat or Steam Sterilization
[00643169544994]
Moist Heat or Steam Sterilization
[00643169544994]
Moist Heat or Steam Sterilization
[00643169544994]
Moist Heat or Steam Sterilization
[00643169544994]
Moist Heat or Steam Sterilization
[00643169544994]
Moist Heat or Steam Sterilization
[00643169544994]
Moist Heat or Steam Sterilization
[00643169544994]
Moist Heat or Steam Sterilization
[00643169544994]
Moist Heat or Steam Sterilization
[00643169544994]
Moist Heat or Steam Sterilization
[00643169544994]
Moist Heat or Steam Sterilization
[00643169544994]
Moist Heat or Steam Sterilization
[00643169544994]
Moist Heat or Steam Sterilization
[00643169544994]
Moist Heat or Steam Sterilization
[00643169544994]
Moist Heat or Steam Sterilization
[00643169544994]
Moist Heat or Steam Sterilization
[00643169544994]
Moist Heat or Steam Sterilization
[00643169544994]
Moist Heat or Steam Sterilization
[00643169544994]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-03-16 |
On-Brand Devices [CD HORIZON® SOLERA® VOYAGER™ Spinal System]
| 00643169890008 | TRAY 1664021 4.75 CDHSV GEN INSTRUMENTS |
| 00643169886551 | LID 1664022 TAB EXTENDER CADDY LID |
| 00643169885134 | TRAY 1664019 CDHS VOYAGER 4.75 ATS |
| 00643169880214 | SCREW 55850014515 5.5 VOYAGER MAS 4.5X15 |
| 00643169880207 | SCREW 54750047560 SV 4.75 ATS 7.5X60 ST |
| 00643169880191 | SCREW 54750047555 SV 4.75 ATS 7.5X55 ST |
| 00643169880184 | SCREW 54750047550 SV 4.75 ATS 7.5X50 ST |
| 00643169880177 | SCREW 54750047545 SV 4.75 ATS 7.5X45 ST |
| 00643169880160 | SCREW 54750047540 SV 4.75 ATS 7.5X40 ST |
| 00643169880153 | SCREW 54750047535 SV 4.75 ATS 7.5X35 ST |
| 00643169880146 | SCREW 54750047530 SV 4.75 ATS 7.5X30 ST |
| 00643169880139 | SCREW 54750047525 SV 4.75 ATS 7.5X25 ST |
| 00643169880122 | SCREW 54750047520 SV 4.75 ATS 7.5X20 ST |
| 00643169880115 | SCREW 54750046560 SV 4.75 ATS 6.5X60 ST |
| 00643169880108 | SCREW 54750046555 SV 4.75 ATS 6.5X55 ST |
| 00643169880092 | SCREW 54750046550 SV 4.75 ATS 6.5X50 ST |
| 00643169880085 | SCREW 54750046545 SV 4.75 ATS 6.5X45 ST |
| 00643169880078 | SCREW 54750046540 SV 4.75 ATS 6.5X40 ST |
| 00643169880061 | SCREW 54750046535 SV 4.75 ATS 6.5X35 ST |
| 00643169880054 | SCREW 54750046530 SV 4.75 ATS 6.5X30 ST |
| 00643169880047 | SCREW 54750046525 SV 4.75 ATS 6.5X25 ST |
| 00643169880030 | SCREW 54750046520 SV 4.75 ATS 6.5X20 ST |
| 00643169880023 | SCREW 54750045560 SV 4.75 ATS 5.5X60 ST |
| 00643169880016 | SCREW 54750045555 SV 4.75 ATS 5.5X55 ST |
| 00643169880009 | SCREW 54750045550 SV 4.75 ATS 5.5X50 ST |
| 00643169879997 | SCREW 54750045545 SV 4.75 ATS 5.5X45 ST |
| 00643169879980 | SCREW 54750045540 SV 4.75 ATS 5.5X40 ST |
| 00643169879973 | SCREW 54750045535 SV 4.75 ATS 5.5X35 ST |
| 00643169879966 | SCREW 54750045530 SV 4.75 ATS 5.5X30 ST |
| 00643169879959 | SCREW 54750045525 SV 4.75 ATS 5.5X25 ST |
| 00643169879942 | SCREW 54750045520 SV 4.75 ATS 5.5X20 ST |
| 00643169879935 | SCREW 54750044560 SV 4.75 ATS 4.5X60 ST |
| 00643169879928 | SCREW 54750044555 SV 4.75 ATS 4.5X55 ST |
| 00643169879911 | SCREW 54750044550 SV 4.75 ATS 4.5X50 ST |
| 00643169879904 | SCREW 54750044545 SV 4.75 ATS 4.5X45 ST |
| 00643169879898 | SCREW 54750044540 SV 4.75 ATS 4.5X40 ST |
| 00643169879881 | SCREW 54750044535 SV 4.75 ATS 4.5X35 ST |
| 00643169879874 | SCREW 54750044530 SV 4.75 ATS 4.5X30 ST |
| 00643169879867 | SCREW 54750044525 SV 4.75 ATS 4.5X25 ST |
| 00643169879850 | SCREW 54750044520 SV 4.75 ATS 4.5X20 ST |
| 00643169833944 | SCREW 54850047560 4.75VOYAGER ATS 7.5X60 |
| 00643169833937 | SCREW 54850047530 4.75VOYAGER ATS 7.5X30 |
| 00643169833920 | SCREW 54850047525 4.75VOYAGER ATS 7.5X25 |
| 00643169833913 | SCREW 54850047520 4.75VOYAGER ATS 7.5X20 |
| 00643169833906 | SCREW 54850046560 4.75VOYAGER ATS 6.5X60 |
| 00643169833890 | SCREW 54850046555 4.75VOYAGER ATS 6.5X55 |
| 00643169833883 | SCREW 54850046525 4.75VOYAGER ATS 6.5X25 |
| 00643169833876 | SCREW 54850046520 4.75VOYAGER ATS 6.5X20 |
| 00643169833869 | SCREW 54850045560 4.75VOYAGER ATS 5.5X60 |
| 00643169833852 | SCREW 54850045555 4.75VOYAGER ATS 5.5X55 |
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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