CD HORIZON® SOLERA® Spinal System
GUDID 00643169490963
ROD 641000030 30MM PERC ROD 4.75MM CCM
MEDTRONIC SOFAMOR DANEK, INC.
Bone-screw internal spinal fixation system, non-sterile| Primary Device ID | 00643169490963 |
| NIH Device Record Key | 7fd03148-e99b-4456-bb81-0881c76aec3b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CD HORIZON® SOLERA® Spinal System |
| Version Model Number | 641000030 |
| 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 Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643169490963 [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 |
[00643169490963]
Moist Heat or Steam Sterilization
[00643169490963]
Moist Heat or Steam Sterilization
[00643169490963]
Moist Heat or Steam Sterilization
[00643169490963]
Moist Heat or Steam Sterilization
[00643169490963]
Moist Heat or Steam Sterilization
[00643169490963]
Moist Heat or Steam Sterilization
[00643169490963]
Moist Heat or Steam Sterilization
[00643169490963]
Moist Heat or Steam Sterilization
[00643169490963]
Moist Heat or Steam Sterilization
[00643169490963]
Moist Heat or Steam Sterilization
[00643169490963]
Moist Heat or Steam Sterilization
[00643169490963]
Moist Heat or Steam Sterilization
[00643169490963]
Moist Heat or Steam Sterilization
[00643169490963]
Moist Heat or Steam Sterilization
[00643169490963]
Moist Heat or Steam Sterilization
[00643169490963]
Moist Heat or Steam Sterilization
[00643169490963]
Moist Heat or Steam Sterilization
[00643169490963]
Moist Heat or Steam Sterilization
[00643169490963]
Moist Heat or Steam Sterilization
[00643169490963]
Moist Heat or Steam Sterilization
[00643169490963]
Moist Heat or Steam Sterilization
[00643169490963]
Moist Heat or Steam Sterilization
[00643169490963]
Moist Heat or Steam Sterilization
[00643169490963]
Moist Heat or Steam Sterilization
[00643169490963]
Moist Heat or Steam Sterilization
[00643169490963]
Moist Heat or Steam Sterilization
[00643169490963]
Moist Heat or Steam Sterilization
[00643169490963]
Moist Heat or Steam Sterilization
[00643169490963]
Moist Heat or Steam Sterilization
[00643169490963]
Moist Heat or Steam Sterilization
[00643169490963]
Moist Heat or Steam Sterilization
[00643169490963]
Moist Heat or Steam Sterilization
[00643169490963]
Moist Heat or Steam Sterilization
[00643169490963]
Moist Heat or Steam Sterilization
[00643169490963]
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® Spinal System]
| 00643169976566 | ROD X0415073 DUAL BEND 6.0 CCM PLS X 490 |
| 00643169976559 | ROD X0415072 DUAL BEND 6.0 CCM PLS L 400 |
| 00643169976542 | ROD X0415071 DUAL BEND 6.0 CCM PLS S 350 |
| 00643169841529 | TRANS HOOK X0516107 30 DEG-NRW-SML-L |
| 00643169841512 | TRANS HOOK X0516106 30 DEG-NRW-SML-R |
| 00643169841505 | TRANS HOOK X0516105 30 DEG-NRW-MED-L |
| 00643169841499 | TRANS HOOK X0516104 30 DEG-NRW-MED-R |
| 00643169841482 | TRANS HOOK X0516103 30 DEG-NRW-LRG-L |
| 00643169841475 | TRANS HOOK X0516102 30 DEG-NRW-LRG-R |
| 00643169841468 | TRANS HOOK X0516101 45 DEG-NRW-SML-L |
| 00643169841451 | TRANS HOOK X0516100 45 DEG-NRW-SML-R |
| 00643169841444 | TRANS HOOK X0516099 45 DEG-NRW-MED-L |
| 00643169841437 | TRANS HOOK X0516098 45 DEG-NRW-MED-R |
| 00643169841420 | TRANS HOOK X0516097 45 DEG-NRW-LRG-L |
| 00643169841413 | TRANS HOOK X0516096 45 DEG-NRW-LRG-R |
| 00643169841406 | TRANS HOOK X0516095 30 DEG-WIDE-SML-L |
| 00643169841390 | TRANS HOOK X0516094 30 DEG-WIDE-SML-R |
| 00643169841383 | TRANS HOOK X0516093 30 DEG-WIDE-MED-L |
| 00643169841376 | TRANS HOOK X0516092 30 DEG-WIDE-MED-R |
| 00643169841369 | TRANS HOOK X0516091 30 DEG-WIDE-LRG-L |
| 00643169841352 | TRANS HOOK X0516090 30 DEG-WIDE-LRG-R |
| 00643169841345 | TRANS HOOK X0516048 45 DEG-WIDE-SML-L |
| 00643169841338 | TRANS HOOK X0516047 45 DEG-WIDE-SML-R |
| 00643169841321 | TRANS HOOK X0516046 45 DEG-WIDE-MED-L |
| 00643169841314 | TRANS HOOK X0516045 45 DEG-WIDE-MED-R |
| 00643169841307 | TRANS HOOK X0316003 45 DEG-WIDE-LRG-L |
| 00643169841291 | TRANS HOOK X0316002 45 DEG-WIDE-LRG-R |
| 00643169834309 | SCREW 55840047560 5.5SOLERAMAS-ATS7.5X60 |
| 00643169834293 | SCREW 55840047555 5.5SOLERAMAS-ATS7.5X55 |
| 00643169834286 | SCREW 55840047550 5.5SOLERAMAS-ATS7.5X50 |
| 00643169834279 | SCREW 55840047545 5.5SOLERAMAS-ATS7.5X45 |
| 00643169834262 | SCREW 55840047540 5.5SOLERAMAS-ATS7.5X40 |
| 00643169834255 | SCREW 55840047535 5.5SOLERAMAS-ATS7.5X35 |
| 00643169834248 | SCREW 55840047530 5.5SOLERAMAS-ATS7.5X30 |
| 00643169834231 | SCREW 55840047525 5.5SOLERAMAS-ATS7.5X25 |
| 00643169834224 | SCREW 55840047520 5.5SOLERAMAS-ATS7.5X20 |
| 00643169834217 | SCREW 55840046560 5.5SOLERAMAS-ATS6.5X60 |
| 00643169834200 | SCREW 55840046555 5.5SOLERAMAS-ATS6.5X55 |
| 00643169834194 | SCREW 55840046550 5.5SOLERAMAS-ATS6.5X50 |
| 00643169834187 | SCREW 55840046545 5.5SOLERAMAS-ATS6.5X45 |
| 00643169834170 | SCREW 55840046540 5.5SOLERAMAS-ATS6.5X40 |
| 00643169834163 | SCREW 55840046535 5.5SOLERAMAS-ATS6.5X35 |
| 00643169834156 | SCREW 55840046530 5.5SOLERAMAS-ATS6.5X30 |
| 00643169834149 | SCREW 55840046525 5.5SOLERAMAS-ATS6.5X25 |
| 00643169834132 | SCREW 55840046520 5.5SOLERAMAS-ATS6.5X20 |
| 00643169834125 | SCREW 55840045560 5.5SOLERAMAS-ATS5.5X60 |
| 00643169834118 | SCREW 55840045555 5.5SOLERAMAS-ATS5.5X55 |
| 00643169834101 | SCREW 55840045550 5.5SOLERAMAS-ATS5.5X50 |
| 00643169834095 | SCREW 55840045545 5.5SOLERAMAS-ATS5.5X45 |
| 00643169834088 | SCREW 55840045540 5.5SOLERAMAS-ATS5.5X40 |
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.