coflex-F™ Screw Inserter
GUDID 04260148890383
Paradigm Spine, LLC
Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable| Primary Device ID | 04260148890383 |
| NIH Device Record Key | 07f2725d-81ab-4cee-8acd-30f413a3a0e5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | coflex-F™ Screw Inserter |
| Version Model Number | RAT20211 |
| Company DUNS | 787874960 |
| Company Name | Paradigm Spine, LLC |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04260148890383 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K093438
FDA Product Code
| KWP | Appliance, Fixation, Spinal Interlaminal |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[04260148890383]
Moist Heat or Steam Sterilization
[04260148890383]
Moist Heat or Steam Sterilization
[04260148890383]
Moist Heat or Steam Sterilization
[04260148890383]
Moist Heat or Steam Sterilization
[04260148890383]
Moist Heat or Steam Sterilization
[04260148890383]
Moist Heat or Steam Sterilization
[04260148890383]
Moist Heat or Steam Sterilization
[04260148890383]
Moist Heat or Steam Sterilization
[04260148890383]
Moist Heat or Steam Sterilization
[04260148890383]
Moist Heat or Steam Sterilization
[04260148890383]
Moist Heat or Steam Sterilization
[04260148890383]
Moist Heat or Steam Sterilization
[04260148890383]
Moist Heat or Steam Sterilization
[04260148890383]
Moist Heat or Steam Sterilization
[04260148890383]
Moist Heat or Steam Sterilization
[04260148890383]
Moist Heat or Steam Sterilization
[04260148890383]
Moist Heat or Steam Sterilization
[04260148890383]
Moist Heat or Steam Sterilization
[04260148890383]
Moist Heat or Steam Sterilization
[04260148890383]
Moist Heat or Steam Sterilization
[04260148890383]
Moist Heat or Steam Sterilization
[04260148890383]
Moist Heat or Steam Sterilization
[04260148890383]
Moist Heat or Steam Sterilization
[04260148890383]
Moist Heat or Steam Sterilization
[04260148890383]
Moist Heat or Steam Sterilization
[04260148890383]
Moist Heat or Steam Sterilization
[04260148890383]
Moist Heat or Steam Sterilization
[04260148890383]
Moist Heat or Steam Sterilization
[04260148890383]
Moist Heat or Steam Sterilization
[04260148890383]
Moist Heat or Steam Sterilization
[04260148890383]
Moist Heat or Steam Sterilization
[04260148890383]
Moist Heat or Steam Sterilization
[04260148890383]
Moist Heat or Steam Sterilization
[04260148890383]
Moist Heat or Steam Sterilization
[04260148890383]
Moist Heat or Steam Sterilization
[04260148890383]
Moist Heat or Steam Sterilization
[04260148890383]
Moist Heat or Steam Sterilization
[04260148890383]
Moist Heat or Steam Sterilization
[04260148890383]
Moist Heat or Steam Sterilization
[04260148890383]
Moist Heat or Steam Sterilization
[04260148890383]
Moist Heat or Steam Sterilization
[04260148890383]
Moist Heat or Steam Sterilization
[04260148890383]
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 | 2017-06-29 |
Devices Manufactured by Paradigm Spine, LLC
| 04260148898235 - CoFix Implant 8 mm | 2020-03-27 |
| 04260148898242 - CoFix Implant 10 mm | 2020-03-27 |
| 04260148898259 - CoFix Implant 12 mm | 2020-03-27 |
| 04260148898266 - CoFix Implant 14 mm | 2020-03-27 |
| 04260148898273 - CoFix Implant 16 mm | 2020-03-27 |
| 04260148897931 - CoFix Sterilization Tray | 2020-03-12 |
| 04260636670459 - coflex-F LIS screw inserter | 2020-03-12 |
| 04260148896927 - DSS HP Polyaxial pedicle screw set, Ø5 x 45mm | 2019-09-26 |
Trademark Results [coflex-F]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 COFLEX-F 77942097 3955728 Live/Registered |
Paradigm Spine, LLC 2010-02-23 |
 COFLEX-F 77027203 not registered Dead/Abandoned |
Paradigm Spine, LLC 2006-10-23 |
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