510(k) K200927
- Device
- Transept Cervical Plate System
- Applicant
- Neurostructures, Inc.
- 510(k) number
- K200927
- Product code
- KWQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2020-07-24
- Date received
- 2020-04-07
- 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
- Moti Altarac
- Address
- 199 Technology Dr. Suite 110 Irvine CA US 92618 92618
FDA Registration Numbers#
- 1935627
- 3007728266
- 3017565094
- 3008812560
- 3004049923
- 3015709929
- 3007993775
- 1417485
- 3005739886
- 3004024955
- 3010509633
- 3010365473
- 3010143171
- 1644312
- 3005180920
- 1424434
- 3016438694
- 3011556898
- 3015941638
- 3012764194
- 3023138345
- 3005819474
- 3020282716
- 3010663372
- 3010440433
- 3007922509
- 1223434
- 3009169996
- 3012711663
- 3010120135
- 3008868758
- 3014252644
- 1828288
- 3009165919
- 1834331
- 3007485169
- 3010041499
- 1057425
- 3043543260
- 3009790163
- 3010370880
- 3005677016
- 2133928
- 3016084569
- 1824199
- 3009962553
- 3008455034
- 3005325790
- 3016496998
- 3008114965
- 3000170817
- 1649518
- 3008534770
- 3010009693
- 3015426608
- 3012447612
- 3012120772
- 3005360851
- 2648623
- 3009417901
- 9611813
- 3005874553
- 3014257776
- 3014937101
- 9612420
- 3010120104
- 3004638600
- 2183449
- 3011302058
- 3025457095
- 3009971621
- 1835444
- 3010560653
- 1832228
- 3009973505
- 1835831
- 3023852420
- 3039103971
- 8043792
- 3010197239
Source Documents#
Other 510(k) Records For Product Code KWQ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K262149 | corra® cervical plating system | Carlsmed, Inc. | 2026-09-24 |
| 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 |
Legacy Summary#
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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