510(k) K211712
- Device
- 3° Anterior Cervical Plating System, Reliant Anterior Cervical Plating System, Unity Lumbosacral Fixation System, Hallmark Anterior Plate System, NewBridge Laminoplasty Fixation System, CETRA Anterior Cervical Plate System
- Applicant
- Orthofix US LLC
- 510(k) number
- K211712
- Product code
- KWQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-02-11
- Date received
- 2021-06-03
- Regulation
- 888.3060
- Classification name
- Appliance, Fixation, Spinal Intervertebral Body
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Jacki Koch
- Address
- 3451 Plano Pkwy. Lewisville TX US 75056 75056
FDA Registration Numbers#
- 3014273424
- 3009962553
- 3013194153
- 3010365473
- 3009957608
- 3008110533
- 3010041993
- 3014938863
- 3010047454
- 3009049161
- 3008868758
- 2028632
- 2245304
- 3014725904
- 3006378738
- 3010097171
- 3011301313
- 2031966
- 3009756327
- 3010560653
- 3010120148
- 3004024955
- 3020282716
- 3000170817
- 1220477
- 3011530718
- 3009888740
- 3003761012
- 3008583793
- 3018210489
- 3010160527
- 3017528621
- 3005031160
- 3006272282
- 3009417901
- 3015831087
- 3012120772
- 3027807601
- 3004961578
- 1417485
- 1420032
- 3013422236
- 1527105
- 1835831
- 3009169996
- 1935627
- 1649379
- 3009704301
- 1828464
- 2134285
- 3006801265
- 1834331
- 3009941480
- 3009217531
- 3006082533
- 1030489
- 1424263
- 3015941638
- 3009051471
- 3011874600
- 3017936978
- 9611390
- 3030412764
- 2032098
- 1833920
- 3012764194
- 3004464325
- 3010440433
- 3012131184
- 3009106092
- 3010057495
- 3004941535
- 3001239363
- 3017521423
- 3007675554
- 3007441485
- 3016237080
- 3010120135
- 3015877656
- 1224360
Source Documents#
Other 510(k) Records For Product Code KWQ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252776 | ARIES Anterior Cervical Plate Systems | ZheJiang Decans Medical Devices Co., Ltd. | 2026-05-14 |
| K261112 | CastleLoc-P Anterior Cervical Plate System | L&K BIOMED Co., Ltd. | 2026-05-06 |
| K260570 | corra™ cervical plating system | Carlsmed, Inc. | 2026-04-22 |
| K260697 | VyPlate™ Anterior Cervical Plate System | Vy Spine, LLC | 2026-03-27 |
| K260015 | ANTERIS Thoracolumbar Plate System | SpineCraft | 2026-03-04 |
| K251940 | PathLoc Lumbar Plate System | L&K BIOMED Co., Ltd. | 2026-03-03 |
| K254182 | Aster | Osteonic Co., Ltd. | 2026-02-26 |
| K253201 | Lumbar Spine Truss System - Plating Solution (LSTS-PS) | 4Web, Inc. | 2026-02-12 |
| K252611 | aprevo® cervical plating system | Carlsmed, Inc. | 2025-12-22 |
| K251965 | Proximity Anterior Cervical Plate System; Segmental Plating System (SPS) | Alphatec Spine, Inc. | 2025-08-28 |
| K251436 | Resolve Anterior Cervical Plate System | Pioneer Surgical Technology, Inc. | 2025-07-11 |
| K250446 | Frida™ Anterior Cervical Plate System | Spineup, Inc. | 2025-05-23 |
| K250602 | X-PAC® N-GAGE™ Lumbar Plate System | Expanding Innovations, Inc. | 2025-05-20 |
| K250486 | Skyway Anterior Cervical Plate System | Kyocera Medical Technologies Inc. (KMTI) | 2025-04-10 |
| K243904 | Elegance® Anterior Cervical plate | Clariance | 2025-01-14 |
Legacy Summary#
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FDA Review#
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