510(k) K210286
- Device
- Cure 2.0 Anterior Cervical Plate (ACP) System
- Applicant
- Meditech Spine, LLC
- 510(k) number
- K210286
- Product code
- KWQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-03-18
- Date received
- 2021-02-02
- Regulation
- 888.3060
- Classification name
- Appliance, Fixation, Spinal Intervertebral Body
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Bruce Dunaway
- Address
- 1447 Peachtree St. NE Suite 440 Atlanta GA US 30309 30309
FDA Registration Numbers#
- 3003541440
- 1834379
- 3004142400
- 9612420
- 3015212339
- 3010531060
- 3012599928
- 1720929
- 1000200989
- 9615800
- 1649379
- 3005031160
- 3006783837
- 2031093
- 3012120772
- 3010197239
- 3010370500
- 3007210720
- 3012711663
- 3010123256
- 3008526708
- 3014678447
- 3004717358
- 1225675
- 3010663372
- 1417485
- 2530808
- 3005180920
- 3015399803
- 2648623
- 3031240334
- 3043543260
- 3007922509
- 3010462278
- 3030412764
- 3010120326
- 3010049501
- 3010032903
- 1221053
- 2531195
- 3010123206
- 3017521423
- 2133928
- 2024024
- 1835251
- 3011301313
- 3010560653
- 3014655115
- 3010365473
- 3010160527
- 2027467
- 3025603301
- 3000170817
- 1043214
- 3009217531
- 9615021
- 3012994232
- 3016438694
- 3011127597
- 1221763
- 3008534770
- 1835831
- 3006017180
- 3010287685
- 3015709929
- 3006272282
- 3010863450
- 3016112537
- 3015440604
- 3011390763
- 1422634
- 3010363503
- 3007923096
- 3014252644
- 9615128
- 3006378738
- 1220477
- 3009756327
- 3010097171
Source Documents#
Other 510(k) Records For Product Code KWQ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261309 | Palisades™ Buttress Plate System | Bethesda Medical Devices, LLC | 2026-07-16 |
| 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 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases