Polarfix™ Facet Screw System
GUDID 08800037500212
Innosys Co., Ltd.
Surgical countersink, single-use| Primary Device ID | 08800037500212 |
| NIH Device Record Key | 8475f59b-72de-41b5-bb11-ecc540e8620f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Polarfix™ Facet Screw System |
| Version Model Number | FSA5530N |
| Company DUNS | 688811082 |
| Company Name | Innosys Co., Ltd. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | true |
| 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 | 08800037500212 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K173198
FDA Product Code
| MRW | SYSTEM, FACET SCREW SPINAL DEVICE |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08800037500212]
Moist Heat or Steam Sterilization
[08800037500212]
Moist Heat or Steam Sterilization
[08800037500212]
Moist Heat or Steam Sterilization
[08800037500212]
Moist Heat or Steam Sterilization
[08800037500212]
Moist Heat or Steam Sterilization
[08800037500212]
Moist Heat or Steam Sterilization
[08800037500212]
Moist Heat or Steam Sterilization
[08800037500212]
Moist Heat or Steam Sterilization
[08800037500212]
Moist Heat or Steam Sterilization
[08800037500212]
Moist Heat or Steam Sterilization
[08800037500212]
Moist Heat or Steam Sterilization
[08800037500212]
Moist Heat or Steam Sterilization
[08800037500212]
Moist Heat or Steam Sterilization
[08800037500212]
Moist Heat or Steam Sterilization
[08800037500212]
Moist Heat or Steam Sterilization
[08800037500212]
Moist Heat or Steam Sterilization
[08800037500212]
Moist Heat or Steam Sterilization
[08800037500212]
Moist Heat or Steam Sterilization
[08800037500212]
Moist Heat or Steam Sterilization
[08800037500212]
Moist Heat or Steam Sterilization
[08800037500212]
Moist Heat or Steam Sterilization
[08800037500212]
Moist Heat or Steam Sterilization
[08800037500212]
Moist Heat or Steam Sterilization
[08800037500212]
Moist Heat or Steam Sterilization
[08800037500212]
Moist Heat or Steam Sterilization
[08800037500212]
Moist Heat or Steam Sterilization
[08800037500212]
Moist Heat or Steam Sterilization
[08800037500212]
Moist Heat or Steam Sterilization
[08800037500212]
Moist Heat or Steam Sterilization
[08800037500212]
Moist Heat or Steam Sterilization
[08800037500212]
Moist Heat or Steam Sterilization
[08800037500212]
Moist Heat or Steam Sterilization
[08800037500212]
Moist Heat or Steam Sterilization
[08800037500212]
Moist Heat or Steam Sterilization
[08800037500212]
Moist Heat or Steam Sterilization
[08800037500212]
Moist Heat or Steam Sterilization
[08800037500212]
Moist Heat or Steam Sterilization
[08800037500212]
Moist Heat or Steam Sterilization
[08800037500212]
Moist Heat or Steam Sterilization
[08800037500212]
Moist Heat or Steam Sterilization
[08800037500212]
Moist Heat or Steam Sterilization
[08800037500212]
Moist Heat or Steam Sterilization
[08800037500212]
Moist Heat or Steam Sterilization
[08800037500212]
Moist Heat or Steam Sterilization
[08800037500212]
Moist Heat or Steam Sterilization
[08800037500212]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2023-06-19 |
| Device Publish Date | 2018-08-21 |
On-Brand Devices [Polarfix™ Facet Screw System]
| 08800037500250 | FSA5550N |
| 08800037500243 | FSA5545N |
| 08800037500236 | FSA5540N |
| 08800037500229 | FSA5535N |
| 08800037500212 | FSA5530N |
| 08800037500205 | FSA5525N |
| 08800037500199 | FSA4550N |
| 08800037500182 | FSA4545N |
| 08800037500175 | FSA4540N |
| 08800037500168 | FSA4535N |
| 08800037500151 | FSA4530N |
| 08800037500144 | FSA4525N |
| 08800015994866 | FS0080 |
| 08800015994859 | FS0070 |
| 08800015994842 | FS0060 |
| 08800015994835 | FS0050 |
| 08800015994828 | FS0040 |
| 08800015994811 | FS0030 |
| 08800015994804 | FS0020 |
| 08800015994798 | FS0010 |
| 08800015994781 | FSA5550 |
| 08800015994774 | FSA5545 |
| 08800015994767 | FSA5540 |
| 08800015994750 | FSA5535 |
| 08800015994743 | FSA5530 |
| 08800015994736 | FSA5525 |
| 08800015994729 | FSA4550 |
| 08800015994712 | FSA4545 |
| 08800015994705 | FSA4540 |
| 08800015994699 | FSA4535 |
| 08800015994682 | FSA4530 |
| 08800015994675 | FSA4525 |
| 08800037586186 | FS0050 |
| 08800037586179 | FS0040 |
| 08800037586162 | FS0010 |
Trademark Results [Polarfix]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 POLARFIX 76520289 not registered Dead/Abandoned |
Polarfix Trading Technologies, Inc 2003-06-06 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.