510(k) K233640
- Device
- Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS Interbody System; Transcend SPS Interbody System;Transcend NanoTec SPS Interbody System
- Applicant
- Alphatec Spine, Inc.
- 510(k) number
- K233640
- Product code
- KWQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-02-22
- Date received
- 2023-11-13
- 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
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Applicant Contact
- Contact
- Andrew Zhang
- Address
- 1950 Camino Vida Roble Carlsbad CA US 92008 92008
FDA Registration Numbers
- 3015709929
- 1450662
- 3004464325
- 3014252644
- 2031917
- 3001239363
- 3023852420
- 1834331
- 3003541440
- 3013194153
- 3009962553
- 1833824
- 3002807112
- 2031093
- 3009504230
- 3000170817
- 3008754074
- 3017521423
- 3021945817
- 1045254
- 9612277
- 3009756327
- 3010863450
- 3019767615
- 3006128100
- 3019837678
- 1225838
- 1030489
- 3004719693
- 1649379
- 2183449
- 3004024955
- 3012120772
- 3010365473
- 3009189869
- 3009887475
- 3023138345
- 1221053
- 3010047454
- 3009973505
- 3009554293
- 3010287685
- 2087234
- 2032112
- 3012447612
- 3012599928
- 3011513267
- 2531195
- 3006017180
- 3016237080
- 1835296
- 3003898943
- 2029275
- 9615128
- 3004049923
- 3008992889
- 3010531060
- 3004893332
- 1833986
- 1528646
- 1722511
- 3011181154
- 3005226664
- 3016084569
- 3009165919
- 3011277306
- 3003526896
- 8010468
- 3010370500
- 3004788213
- 3010120148
- 3009144915
- 8043792
- 3015877656
- 3007485169
- 1836357
- 3007014520
- 3018094310
- 1423662
- 3004176895
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|
| 00190376545165 | Segmental Plating System | ALPHATEC SPINE, INC. | 2024-11-12 |
| 00190376545325 | Segmental Plating System | ALPHATEC SPINE, INC. | 2024-11-12 |
| 00190376545332 | Segmental Plating System | ALPHATEC SPINE, INC. | 2024-11-12 |
| 00190376545189 | Segmental Plating System | ALPHATEC SPINE, INC. | 2024-11-12 |
| 00190376545257 | Segmental Plating System | ALPHATEC SPINE, INC. | 2024-11-12 |
| 00190376545226 | Segmental Plating System | ALPHATEC SPINE, INC. | 2024-11-12 |
| 00190376545271 | Segmental Plating System | ALPHATEC SPINE, INC. | 2024-11-12 |
| 00190376545158 | Segmental Plating System | ALPHATEC SPINE, INC. | 2024-11-12 |
| 00190376545196 | Segmental Plating System | ALPHATEC SPINE, INC. | 2024-11-12 |
| 00190376545233 | Segmental Plating System | ALPHATEC SPINE, INC. | 2024-11-12 |
| 00190376545356 | Segmental Plating System | ALPHATEC SPINE, INC. | 2024-11-12 |
| 00190376545264 | Segmental Plating System | ALPHATEC SPINE, INC. | 2024-11-12 |
| 00190376545363 | Segmental Plating System | ALPHATEC SPINE, INC. | 2024-11-12 |
| 00190376545172 | Segmental Plating System | ALPHATEC SPINE, INC. | 2024-11-12 |
| 00190376545349 | Segmental Plating System | ALPHATEC SPINE, INC. | 2024-11-12 |
| 00190376545318 | Segmental Plating System | ALPHATEC SPINE, INC. | 2024-11-12 |
| 00190376545240 | Segmental Plating System | ALPHATEC SPINE, INC. | 2024-11-12 |
| 00190376545141 | Segmental Plating System | ALPHATEC SPINE, INC. | 2024-11-12 |
| 00190376545110 | Segmental Plating System | ALPHATEC SPINE, INC. | 2024-07-23 |
| 00190376545219 | Segmental Plating System | ALPHATEC SPINE, INC. | 2024-07-23 |
| 00190376538792 | Segmental Plating System | ALPHATEC SPINE, INC. | 2024-07-23 |
| 00190376545127 | Segmental Plating System | ALPHATEC SPINE, INC. | 2024-07-23 |
| 00190376545134 | Segmental Plating System | ALPHATEC SPINE, INC. | 2024-07-23 |
| 00190376545202 | Segmental Plating System | ALPHATEC SPINE, INC. | 2024-07-23 |
| 00190376545868 | Segmental Plating System | ALPHATEC SPINE, INC. | 2024-06-28 |
| 00190376545820 | Segmental Plating System | ALPHATEC SPINE, INC. | 2024-06-28 |
| 00190376545844 | Segmental Plating System | ALPHATEC SPINE, INC. | 2024-06-28 |
| 00190376545813 | Segmental Plating System | ALPHATEC SPINE, INC. | 2024-06-28 |
| 00190376545851 | Segmental Plating System | ALPHATEC SPINE, INC. | 2024-06-28 |
| 00190376545875 | Segmental Plating System | ALPHATEC SPINE, INC. | 2024-06-28 |
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 |