510(k) K261309
- Device
- Palisades™ Buttress Plate System
- Applicant
- Bethesda Medical Devices, LLC
- 510(k) number
- K261309
- Product code
- KWQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-07-16
- Date received
- 2026-04-21
- 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
- N
Applicant Contact#
- Contact
- Amanda Shade
- Address
- 2985 Nationwide Pkwy. Brunswick OH US 44212 44212
FDA Registration Numbers#
- 3009380063
- 3007922509
- 9617544
- 3010326971
- 2029275
- 1000432246
- 3010057495
- 3012447612
- 2648623
- 1835831
- 3004635447
- 3010123256
- 3004638600
- 3008285983
- 1528646
- 3031261833
- 2032098
- 3007289746
- 3009998573
- 3003387384
- 3010866843
- 1424434
- 3004049923
- 3005819474
- 3006493760
- 3043543260
- 2024024
- 3006404071
- 3009417901
- 3015179588
- 1056553
- 3011795235
- 3023138345
- 3022159082
- 3010440433
- 3011390763
- 1833824
- 1000200989
- 3013548554
- 3010120339
- 3010041430
- 3016112537
- 1045254
- 3009504230
- 3006082533
- 3005874553
- 2531477
- 3021945817
- 3011187779
- 3017936978
- 2530808
- 1423662
- 3003541440
- 3010370554
- 3003526896
- 3006272282
- 3011530718
- 2134947
- 3013055499
- 3009973505
- 3015399803
- 2245304
- 3006356043
- 3010531060
- 3010178296
- 3000170817
- 3010123206
- 3010120135
- 2532027
- 3025603301
- 3015869493
- 3015398319
- 3009446038
- 2031917
- 3016237080
- 3012131184
- 3013194153
- 3010365473
- 3017597868
- 3011301313
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 |