Product code MRW
- Device name
- System, Facet Screw Spinal Device
- Medical specialty
- Unknown
- Device class
- U
- Review panel
- OR
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253676 | CORUS™ Posterior Cervical Stabilization System 3D (CORUS™ PCSS 3D) | Providence Medical Technology, Inc. | 2026-05-14 |
| K253432 | DiversiVy™ Facet Screw System | Vy Spine, LLC | 2026-03-19 |
| K251714 | Ion-C | SurGenTec, LLC | 2026-01-16 |
| K250679 | FFX Facet Fixation System | Sc Medica | 2025-12-04 |
| K253190 | CORUS-LX Implant | Providence Medical Technology, Inc. | 2025-11-20 |
| K252153 | FFX Facet Fixation System | Sc Medica | 2025-10-16 |
| K251885 | CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX Implant | Providence Medical Technology, Inc. | 2025-07-10 |
| K250920 | Arthrex Spine Compression FT Screw | Arthrex, Inc. | 2025-05-22 |
| K242527 | The Karma® Fixation System | Spinal Elements, Inc. | 2025-05-21 |
| K243865 | AERO MIS Facet Fusion System | Aurora Spine | 2025-03-24 |
| K243265 | Ion 3D | SurGenTec, LLC | 2024-12-04 |
| K242650 | zLOCK Lumbar Facet Fixation System | Zygofix , Ltd. | 2024-09-20 |
| K241035 | PMT Posterior Cervical Stabilization System (PCSS) | Providence Medical Technology, Inc. | 2024-06-25 |
| K241416 | Ion 3D | SurGenTec, LLC | 2024-06-17 |
| K232468 | SC Medica FFX | Sc Medica | 2024-05-09 |
| K240085 | zLOCK Lumbar Facet Fixation System | Zygofix , Ltd. | 2024-04-18 |
| K240086 | Ion 3D | SurGenTec, LLC | 2024-02-08 |
| K230840 | PMT Facet Fixation System, Lumbar (PMT FFS-LX) | Providence Medical Technology, Inc. | 2023-12-19 |
| K232877 | FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous Fixation System, and AEON-C™ Stand Alone System | K&J Consulting Corporation | 2023-12-13 |
| K230297 | PMT Expandable Cage (PMT EXP) | Providence Medical Technology, Inc. | 2023-08-11 |
| K220951 | PMT Facet Fixation System (PMT FFS) | Providence Medical Technology, Inc. | 2022-12-09 |
| K222515 | FaSet Fixation System | Dio Medical Corporation | 2022-10-05 |
| K211855 | Ion Facet Screw System | SurGenTec, LLC | 2022-02-25 |
| K192744 | CORRIDOR Fixation System | Globus Medical, Inc. | 2019-12-16 |
| K192281 | AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine System, BOWTI Anterior Buttress Staple Spinal System, DISCOVERY Screw System, EXPEDIUM Anterior Spine System, FRONTIER Anterior Scoliosis System, KAN... | Medos International SARL | 2019-11-20 |
| K183589 | PMT Facet Screw | Providence Medical Technology, Inc. | 2019-10-11 |
| K180729 | FaSet Fixation System | Huvexel Co. , Ltd. | 2018-06-28 |
| K173198 | Facet Screw Fixation System | U&I Corporation | 2018-01-03 |
| K163374 | ALLY™ Facet Screws | Providence Medical Technology, Inc. | 2017-02-16 |
| K161798 | FacetBRIDGE® System | Ldr Spine USA, Inc. | 2016-08-04 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08800039820035 | Faset | DIOMEDICAL CO.,LTD. | 2019-02-08 |
| 08800039820028 | Faset | DIOMEDICAL CO.,LTD. | 2019-02-08 |
| 08800039820011 | Faset | DIOMEDICAL CO.,LTD. | 2019-02-08 |
| 08800039820004 | Faset | DIOMEDICAL CO.,LTD. | 2019-02-08 |
| 08800039819992 | Faset | DIOMEDICAL CO.,LTD. | 2019-02-08 |
| 08800039819985 | Faset | DIOMEDICAL CO.,LTD. | 2019-02-08 |
| 08800039819978 | Faset | DIOMEDICAL CO.,LTD. | 2019-02-08 |
| 08800039819961 | Faset | DIOMEDICAL CO.,LTD. | 2019-02-08 |
| 08800039819954 | Faset | DIOMEDICAL CO.,LTD. | 2019-02-08 |
| 08800039819947 | Faset | DIOMEDICAL CO.,LTD. | 2019-02-08 |
| 08800039819930 | Faset | DIOMEDICAL CO.,LTD. | 2019-02-08 |
| 08800039819923 | Faset | DIOMEDICAL CO.,LTD. | 2019-02-08 |
| 08800039819916 | Faset | DIOMEDICAL CO.,LTD. | 2019-02-08 |
| 08800039819909 | Faset | DIOMEDICAL CO.,LTD. | 2019-02-08 |
| 07613327122138 | OASYS | Stryker Corporation | 2015-09-14 |
| 07613327067552 | OASYS | Stryker Corporation | 2015-09-14 |
| 07613327122121 | OASYS | Stryker Corporation | 2015-09-14 |
| 07613327122114 | OASYS | Stryker Corporation | 2015-09-14 |
| 07613327122107 | OASYS | Stryker Corporation | 2015-09-14 |
| 07613327122091 | OASYS | Stryker Corporation | 2015-09-14 |
| 07613327122077 | OASYS | Stryker Corporation | 2015-09-14 |
| 07613327122060 | OASYS | Stryker Corporation | 2015-09-14 |
| 07613327122046 | OASYS | Stryker Corporation | 2015-09-14 |
| 07613327122039 | OASYS | Stryker Corporation | 2015-09-14 |
| 07613327122022 | OASYS | Stryker Corporation | 2015-09-14 |
| 07613327122015 | OASYS | Stryker Corporation | 2015-09-14 |
| 07613327122008 | OASYS | Stryker Corporation | 2015-09-14 |
| 07613327067590 | OASYS | Stryker Corporation | 2015-09-14 |
| 07613327067576 | OASYS | Stryker Corporation | 2015-09-14 |
| 07613327067569 | OASYS | Stryker Corporation | 2015-09-14 |