CD HORIZON® Spinal System
GUDID 00643169468696
SCREWDRIVER X1013208 6.35MM FAS
MEDTRONIC SOFAMOR DANEK, INC.
Multi-purpose surgical power tool system, line-powered| Primary Device ID | 00643169468696 |
| NIH Device Record Key | 562c4735-95c0-4d6c-97b3-dce689903c33 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CD HORIZON® Spinal System |
| Version Model Number | X1013208 |
| 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
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 Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643169468696 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K143019
FDA Product Code
| HWE | INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00643169468696]
Moist Heat or Steam Sterilization
[00643169468696]
Moist Heat or Steam Sterilization
[00643169468696]
Moist Heat or Steam Sterilization
[00643169468696]
Moist Heat or Steam Sterilization
[00643169468696]
Moist Heat or Steam Sterilization
[00643169468696]
Moist Heat or Steam Sterilization
[00643169468696]
Moist Heat or Steam Sterilization
[00643169468696]
Moist Heat or Steam Sterilization
[00643169468696]
Moist Heat or Steam Sterilization
[00643169468696]
Moist Heat or Steam Sterilization
[00643169468696]
Moist Heat or Steam Sterilization
[00643169468696]
Moist Heat or Steam Sterilization
[00643169468696]
Moist Heat or Steam Sterilization
[00643169468696]
Moist Heat or Steam Sterilization
[00643169468696]
Moist Heat or Steam Sterilization
[00643169468696]
Moist Heat or Steam Sterilization
[00643169468696]
Moist Heat or Steam Sterilization
[00643169468696]
Moist Heat or Steam Sterilization
[00643169468696]
Moist Heat or Steam Sterilization
[00643169468696]
Moist Heat or Steam Sterilization
[00643169468696]
Moist Heat or Steam Sterilization
[00643169468696]
Moist Heat or Steam Sterilization
[00643169468696]
Moist Heat or Steam Sterilization
[00643169468696]
Moist Heat or Steam Sterilization
[00643169468696]
Moist Heat or Steam Sterilization
[00643169468696]
Moist Heat or Steam Sterilization
[00643169468696]
Moist Heat or Steam Sterilization
[00643169468696]
Moist Heat or Steam Sterilization
[00643169468696]
Moist Heat or Steam Sterilization
[00643169468696]
Moist Heat or Steam Sterilization
[00643169468696]
Moist Heat or Steam Sterilization
[00643169468696]
Moist Heat or Steam Sterilization
[00643169468696]
Moist Heat or Steam Sterilization
[00643169468696]
Moist Heat or Steam Sterilization
[00643169468696]
Moist Heat or Steam Sterilization
[00643169468696]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-11-22 |
| Device Publish Date | 2016-07-04 |
On-Brand Devices [CD HORIZON® Spinal System]
| 00613994953216 | SCR X1010761 5.5 RED SAS TI OGTHN 8.0X95 |
| 00613994953209 | SCR X1010762 5.5 RED SAS TI OG 8.0X100 |
| 00613994953193 | SCR X1010750 5.5 RED SAS TI OGTHN 8.0X40 |
| 00613994953186 | SCR X1010738 5.5 RED SAS TI OGTHN 7.5X65 |
| 00613994953179 | SCR X1010739 5.5 RED SAS TI OGTHN 7.5X70 |
| 00613994953162 | SCR X1010740 5.5 RED SAS TI OGTHN 7.5X75 |
| 00613994953155 | SCR X1010741 5.5 RED SAS TI OGTHN 7.5X80 |
| 00613994953148 | SCR X1010742 5.5 RED SAS TI OGTHN 7.5X85 |
| 00613994953131 | SCR X1010743 5.5 RED SAS TI OGTHN 7.5X90 |
| 00613994953124 | SCR X1010744 5.5 RED SAS TI OGTHN 7.5X95 |
| 00613994953117 | SCR X1010745 5.5 RED SAS TI OG 7.5X100 |
| 00613994953100 | SCR X1010746 5.5 RED SAS TI OGTHN 8.0X20 |
| 00613994953094 | SCR X1010747 5.5 RED SAS TI OGTHN 8.0X25 |
| 00613994953087 | SCR X1010748 5.5 RED SAS TI OGTHN 8.0X30 |
| 00613994953070 | SCR X1010749 5.5 RED SAS TI OGTHN 8.0X35 |
| 00613994951021 | SCREW 54890007585 4.75 RMAS 7.5X85 CC |
| 00613994951014 | SCREW 54890007590 4.75 RMAS 7.5X90 CC |
| 00613994951007 | SCREW 54890007595 4.75 RMAS 7.5X95 CC |
| 00613994950994 | SCREW 54890008000 4.75 RMAS 8.0X100 CC |
| 00613994950987 | SCREW 54890008011 4.75 RMAS 8.0X110 CC |
| 00613994950963 | SCREW 54890008085 4.75 RMAS 8.0X85 CC |
| 00613994950956 | SCREW 54890008090 4.75 RMAS 8.0X90 CC |
| 00613994950949 | SCREW 54890008095 4.75 RMAS 8.0X95 CC |
| 00613994950932 | SCREW 54890008500 4.75 RMAS 8.5X100 CC |
| 00613994950925 | SCREW 54890008511 4.75 RMAS 8.5X110 CC |
| 00613994950901 | SCREW 54890008520 4.75 RMAS 8.5X20 CC |
| 00613994950895 | SCREW 54890008525 4.75 RMAS 8.5X25 CC |
| 00613994950888 | SCREW 54890008530 4.75 RMAS 8.5X30 CC |
| 00613994950871 | SCREW 54890008535 4.75 RMAS 8.5X35 CC |
| 00613994950864 | SCREW 54890008540 4.75 RMAS 8.5X40 CC |
| 00613994950857 | SCREW 54890008545 4.75 RMAS 8.5X45 CC |
| 00613994950840 | SCREW 54890008550 4.75 RMAS 8.5X50 CC |
| 00613994950833 | SCREW 54890008555 4.75 RMAS 8.5X55 CC |
| 00613994950826 | SCREW 54890008560 4.75 RMAS 8.5X60 CC |
| 00613994950819 | SCREW 54890007511 4.75 RMAS 7.5X110 CC |
| 00613994950802 | SCREW 54890001000 4.75 RMAS 10.0X100 CC |
| 00613994950796 | SCREW 54890001011 4.75 RMAS 10.0X110 CC |
| 00613994950772 | SCREW 54890001080 4.75 RMAS 10.0X80 CC |
| 00613994950765 | SCREW 54890001085 4.75 RMAS 10.0X85 CC |
| 00613994950758 | SCREW 54890001090 4.75 RMAS 10.0X90 CC |
| 00613994950741 | SCREW 54890001095 4.75 RMAS 10.0X95 CC |
| 00613994950734 | SCREW 54890001500 4.75 RMAS 10.5X100 CC |
| 00613994950727 | SCREW 54890001511 4.75 RMAS 10.5X110 CC |
| 00613994950703 | SCREW 54890001580 4.75 RMAS 10.5X80 CC |
| 00613994950697 | SCREW 54890001585 4.75 RMAS 10.5X85 CC |
| 00613994950680 | SCREW 54890001590 4.75 RMAS 10.5X90 CC |
| 00613994950673 | SCREW 54890001595 4.75 RMAS 10.5X95 CC |
| 00613994950666 | SCREW 54890004015 4.75 RMAS 4.0X15 CC |
| 00613994950659 | SCREW 54890004515 4.75 RMAS 4.5X15 CC |
| 00613994950642 | SCREW 54890005015 4.75 RMAS 5.0X15 CC |
Trademark Results [CD HORIZON]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CD HORIZON 75079759 2108361 Live/Registered |
WARSAW ORTHOPEDIC, INC. 1996-03-28 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.