CD HORIZON® Fenestrated Screw Set
GUDID 00643169679092
MAS 55840028565T 5.5/6.0 FENSTRTD 8.5X65
MEDTRONIC SOFAMOR DANEK, INC.
Bone-screw internal spinal fixation system, non-sterile| Primary Device ID | 00643169679092 |
| NIH Device Record Key | da9d7402-3cea-4912-84a6-9986ec9ad202 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CD HORIZON® Fenestrated Screw Set |
| Version Model Number | 55840028565T |
| 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
| Circumference | 8.5 Millimeter |
| Circumference | 8.5 Millimeter |
| Circumference | 8.5 Millimeter |
| Circumference | 8.5 Millimeter |
| Length | 65 Millimeter |
| Circumference | 8.5 Millimeter |
| Length | 65 Millimeter |
| Circumference | 8.5 Millimeter |
| Length | 65 Millimeter |
| Circumference | 8.5 Millimeter |
| Length | 65 Millimeter |
| Circumference | 8.5 Millimeter |
| Length | 65 Millimeter |
| Circumference | 8.5 Millimeter |
| Length | 65 Millimeter |
| Circumference | 8.5 Millimeter |
| Length | 65 Millimeter |
| Circumference | 8.5 Millimeter |
| Length | 65 Millimeter |
| Circumference | 8.5 Millimeter |
| Length | 65 Millimeter |
| Circumference | 8.5 Millimeter |
| Length | 65 Millimeter |
| Circumference | 8.5 Millimeter |
| Length | 65 Millimeter |
| Circumference | 8.5 Millimeter |
| Length | 65 Millimeter |
| Circumference | 8.5 Millimeter |
| Length | 65 Millimeter |
| Circumference | 8.5 Millimeter |
| Length | 65 Millimeter |
| Circumference | 8.5 Millimeter |
| Length | 65 Millimeter |
| Circumference | 8.5 Millimeter |
| Length | 65 Millimeter |
| Circumference | 8.5 Millimeter |
| Length | 65 Millimeter |
| Circumference | 8.5 Millimeter |
| Length | 65 Millimeter |
| Circumference | 8.5 Millimeter |
| Length | 65 Millimeter |
| Circumference | 8.5 Millimeter |
| Length | 65 Millimeter |
| Circumference | 8.5 Millimeter |
| Length | 65 Millimeter |
| Circumference | 8.5 Millimeter |
| Length | 65 Millimeter |
| Circumference | 8.5 Millimeter |
| Length | 65 Millimeter |
| Circumference | 8.5 Millimeter |
| Length | 65 Millimeter |
| Circumference | 8.5 Millimeter |
| Length | 65 Millimeter |
| Circumference | 8.5 Millimeter |
| Length | 65 Millimeter |
| Circumference | 8.5 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643169679092 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K152604
FDA Product Code
| MNI | ORTHOSIS, SPINAL PEDICLE FIXATION |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00643169679092]
Moist Heat or Steam Sterilization
[00643169679092]
Moist Heat or Steam Sterilization
[00643169679092]
Moist Heat or Steam Sterilization
[00643169679092]
Moist Heat or Steam Sterilization
[00643169679092]
Moist Heat or Steam Sterilization
[00643169679092]
Moist Heat or Steam Sterilization
[00643169679092]
Moist Heat or Steam Sterilization
[00643169679092]
Moist Heat or Steam Sterilization
[00643169679092]
Moist Heat or Steam Sterilization
[00643169679092]
Moist Heat or Steam Sterilization
[00643169679092]
Moist Heat or Steam Sterilization
[00643169679092]
Moist Heat or Steam Sterilization
[00643169679092]
Moist Heat or Steam Sterilization
[00643169679092]
Moist Heat or Steam Sterilization
[00643169679092]
Moist Heat or Steam Sterilization
[00643169679092]
Moist Heat or Steam Sterilization
[00643169679092]
Moist Heat or Steam Sterilization
[00643169679092]
Moist Heat or Steam Sterilization
[00643169679092]
Moist Heat or Steam Sterilization
[00643169679092]
Moist Heat or Steam Sterilization
[00643169679092]
Moist Heat or Steam Sterilization
[00643169679092]
Moist Heat or Steam Sterilization
[00643169679092]
Moist Heat or Steam Sterilization
[00643169679092]
Moist Heat or Steam Sterilization
[00643169679092]
Moist Heat or Steam Sterilization
[00643169679092]
Moist Heat or Steam Sterilization
[00643169679092]
Moist Heat or Steam Sterilization
[00643169679092]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-03-05 |
| Device Publish Date | 2016-04-09 |
On-Brand Devices [CD HORIZON® Fenestrated Screw Set]
| 00643169679429 | DRIVER 7480755T 5.5/6.0 MAS LOCK SLEEVE |
| 00643169679412 | DRIVER 7480745T 4.75 MAS LOCK SLEEVE |
| 00643169679405 | SHAFT 7480741T ADAPTER DRIVER QC SHAFT |
| 00643169679320 | MAS 55840021580T 5.5/6.0 FNSTRTD 10.5X80 |
| 00643169679313 | MAS 55840021575T 5.5/6.0 FNSTRTD 10.5X75 |
| 00643169679306 | MAS 55840021570T 5.5/6.0 FNSTRTD 10.5X70 |
| 00643169679290 | MAS 55840021565T 5.5/6.0 FNSTRTD 10.5X65 |
| 00643169679283 | MAS 55840021560T 5.5/6.0 FNSTRTD 10.5X60 |
| 00643169679276 | MAS 55840021555T 5.5/6.0 FNSTRTD 10.5X55 |
| 00643169679269 | MAS 55840021550T 5.5/6.0 FNSTRTD 10.5X50 |
| 00643169679252 | MAS 55840021545T 5.5/6.0 FNSTRTD 10.5X45 |
| 00643169679245 | MAS 55840021540T 5.5/6.0 FNSTRTD 10.5X40 |
| 00643169679238 | MAS 55840029580T 5.5/6.0 FENSTRTD 9.5X80 |
| 00643169679221 | MAS 55840029575T 5.5/6.0 FENSTRTD 9.5X75 |
| 00643169679214 | MAS 55840029570T 5.5/6.0 FENSTRTD 9.5X70 |
| 00643169679207 | MAS 55840029565T 5.5/6.0 FENSTRTD 9.5X65 |
| 00643169679191 | MAS 55840029560T 5.5/6.0 FENSTRTD 9.5X60 |
| 00643169679184 | MAS 55840029555T 5.5/6.0 FENSTRTD 9.5X55 |
| 00643169679177 | MAS 55840029550T 5.5/6.0 FENSTRTD 9.5X50 |
| 00643169679160 | MAS 55840029545T 5.5/6.0 FENSTRTD 9.5X45 |
| 00643169679153 | MAS 55840029540T 5.5/6.0 FENSTRTD 9.5X40 |
| 00643169679146 | MAS 55840029535T 5.5/6.0 FENSTRTD 9.5X35 |
| 00643169679139 | MAS 55840029530T 5.5/6.0 FENSTRTD 9.5X30 |
| 00643169679122 | MAS 55840028580T 5.5/6.0 FENSTRTD 8.5X80 |
| 00643169679115 | MAS 55840028575T 5.5/6.0 FENSTRTD 8.5X75 |
| 00643169679108 | MAS 55840028570T 5.5/6.0 FENSTRTD 8.5X70 |
| 00643169679092 | MAS 55840028565T 5.5/6.0 FENSTRTD 8.5X65 |
| 00643169679085 | MAS 55840028560T 5.5/6.0 FENSTRTD 8.5X60 |
| 00643169679078 | MAS 55840028555T 5.5/6.0 FENSTRTD 8.5X55 |
| 00643169679061 | MAS 55840028550T 5.5/6.0 FENSTRTD 8.5X50 |
| 00643169679054 | MAS 55840028545T 5.5/6.0 FENSTRTD 8.5X45 |
| 00643169679047 | MAS 55840028540T 5.5/6.0 FENSTRTD 8.5X40 |
| 00643169679030 | MAS 55840028535T 5.5/6.0 FENSTRTD 8.5X35 |
| 00643169679023 | MAS 55840028530T 5.5/6.0 FENSTRTD 8.5X30 |
| 00643169679016 | MAS 55840027580T 5.5/6.0 FENSTRTD 7.5X80 |
| 00643169679009 | MAS 55840027575T 5.5/6.0 FENSTRTD 7.5X75 |
| 00643169678996 | MAS 55840027570T 5.5/6.0 FENSTRTD 7.5X70 |
| 00643169678989 | MAS 55840027565T 5.5/6.0 FENSTRTD 7.5X65 |
| 00643169678972 | MAS 55840027560T 5.5/6.0 FENSTRTD 7.5X60 |
| 00643169678965 | MAS 55840027555T 5.5/6.0 FENSTRTD 7.5X55 |
| 00643169678958 | MAS 55840027550T 5.5/6.0 FENSTRTD 7.5X50 |
| 00643169678941 | MAS 55840027545T 5.5/6.0 FENSTRTD 7.5X45 |
| 00643169678934 | MAS 55840027540T 5.5/6.0 FENSTRTD 7.5X40 |
| 00643169678927 | MAS 55840027535T 5.5/6.0 FENSTRTD 7.5X35 |
| 00643169678910 | MAS 55840027530T 5.5/6.0 FENSTRTD 7.5X30 |
| 00643169678903 | MAS 55840026580T 5.5/6.0 FENSTRTD 6.5X80 |
| 00643169678897 | MAS 55840026575T 5.5/6.0 FENSTRTD 6.5X75 |
| 00643169678880 | MAS 55840026570T 5.5/6.0 FENSTRTD 6.5X70 |
| 00643169678873 | MAS 55840026565T 5.5/6.0 FENSTRTD 6.5X65 |
| 00643169678866 | MAS 55840026560T 5.5/6.0 FENSTRTD 6.5X60 |
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.