510(k) K182473
- Device
- PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate System, CAYMAN Thoracolumbar And Buttress Plate Systems
- Applicant
- K2M Inc.
- 510(k) number
- K182473
- Product code
- KWQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-12-12
- Date received
- 2018-09-10
- 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
- Nancy Giezen
- Address
- 600 Hope Pkwy. SE Leesburg VA US 20175 20175
FDA Registration Numbers#
- 2245304
- 3006755626
- 3009173317
- 3010068573
- 3011390763
- 3014725904
- 3011127597
- 3003541440
- 3009973699
- 3010041430
- 1000200989
- 3009959868
- 1417485
- 3006783837
- 3015179588
- 3006404019
- 3016237080
- 3015426608
- 3004142400
- 3000170817
- 1221763
- 3014937101
- 3015398319
- 3006215390
- 3022159082
- 1319429
- 1528646
- 3004788213
- 2531477
- 3004153896
- 1526439
- 3011187779
- 3014273424
- 3013491327
- 3010032903
- 2027467
- 1720929
- 3005739886
- 3011181154
- 3008534770
- 3012491394
- 3005874553
- 1835831
- 3037407500
- 1828464
- 1833506
- 3010326971
- 3004774118
- 3010531060
- 3012428435
- 3007125392
- 9617544
- 2028632
- 9681465
- 1835444
- 3020703621
- 3010863450
- 2530808
- 1000432246
- 3005977257
- 3006356043
- 3015941638
- 3010143171
- 3013548554
- 3015869493
- 3006404071
- 3007539489
- 3001239363
- 3005076207
- 1836357
- 3010462278
- 3021945817
- 3013422238
- 1833920
- 3018094310
- 1824313
- 3008812560
- 3010365473
- 1526534
- 3009973505
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#
summary
FDA Review#
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