| Primary Device ID | 08800037598172 |
| NIH Device Record Key | da5dea66-c9e4-473b-8c2c-a6c3f58bfcb6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Benefix™ Interspinous Fixation System |
| Version Model Number | ISS2050 |
| Company DUNS | 688811082 |
| Company Name | CG MedTech Co.,Ltd. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | true |
| Manufacturing Date | true |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 08800037598172 [Primary] |
| FZX | Guide, surgical, instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08800037598172]
Moist Heat or Steam Sterilization
[08800037598172]
Moist Heat or Steam Sterilization
[08800037598172]
Moist Heat or Steam Sterilization
[08800037598172]
Moist Heat or Steam Sterilization
[08800037598172]
Moist Heat or Steam Sterilization
[08800037598172]
Moist Heat or Steam Sterilization
[08800037598172]
Moist Heat or Steam Sterilization
[08800037598172]
Moist Heat or Steam Sterilization
[08800037598172]
Moist Heat or Steam Sterilization
[08800037598172]
Moist Heat or Steam Sterilization
[08800037598172]
Moist Heat or Steam Sterilization
[08800037598172]
Moist Heat or Steam Sterilization
[08800037598172]
Moist Heat or Steam Sterilization
[08800037598172]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-02-26 |
| Device Publish Date | 2025-02-18 |
| 08800308499696 - INNOVERSE Spinal System | 2026-01-27 |
| 08800308483183 - ASPIRON™ S ACP SYSTEM | 2026-01-13 |
| 08800308485798 - ASPIRON™ S ACP SYSTEM | 2026-01-13 |
| 08800308485750 - VELOFIX™ PEEK LUMBAR CAGE | 2026-01-06 |
| 08800308485767 - VELOFIX™ PEEK LUMBAR CAGE | 2026-01-06 |
| 08800308485774 - Velofix™ TLIF Cage | 2026-01-06 |
| 08800308485781 - Velofix™ TLIF Cage | 2026-01-06 |
| 08800308483206 - UniSpace® TPLIF Cage | 2025-12-19 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() BENEFIX 87367180 5410614 Live/Registered |
BeneFix, LLC 2017-03-10 |
![]() BENEFIX 87367107 5410613 Live/Registered |
BeneFix, LLC 2017-03-10 |
![]() BENEFIX 78872293 3217619 Live/Registered |
SS&C TECHNOLOGIES, INC. 2006-04-28 |
![]() BENEFIX 75376195 2413376 Dead/Cancelled |
2900084 CANADA INC. 1997-10-20 |
![]() BENEFIX 75038324 2102082 Live/Registered |
GENETICS INSTITUTE, LLC 1995-12-26 |
![]() BENEFIX 74377205 1814054 Dead/Cancelled |
Blue Cross and Blue Shield 1993-04-09 |