510(k) K171439
- Device
- EAGLE Plus Anterior Cervical Plate System, EAGLE Plus Micro Anterior Cervical Plate System, PULSE Anterior Cervical Plate System, SKYLINE Anterior Cervical Plate System, SLIM LOC Anterior Cervical Plate System, SWIFT Plus Anterior Cervical Plate Syst
- Applicant
- Medos International SARL
- 510(k) number
- K171439
- Product code
- KWQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-07-20
- Date received
- 2017-05-16
- 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
- Catherine Kilshaw
- Address
- Chemin-Blanc 38 Lelocle CH 2400 2400
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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