510(k) K992110
- Device
- PREMIER ANTERIOR CERVICAL PLATE SYSTEM
- Applicant
- SOFAMOR DANEK USA
- 510(k) number
- K992110
- Product code
- KWQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1999-09-14
- Date received
- 1999-06-22
- 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
- RICHARD W TREHARNE
- Address
- 1800 Pyramid Pl. Memphis TN US 38132 38132
FDA Registration Numbers#
- 3037407500
- 3010041430
- 3002807112
- 3006846753
- 1057425
- 3009971621
- 3006110997
- 3014725904
- 1030489
- 3015440604
- 3007014520
- 3002976036
- 1835251
- 1834331
- 3004638532
- 1417485
- 3015869121
- 2183946
- 9617297
- 3011530718
- 1835444
- 3009189869
- 1000461041
- 3005706667
- 3013491327
- 1424434
- 3013422238
- 3034676720
- 3009217531
- 3003935342
- 3010365473
- 3011221483
- 3009756327
- 3009169872
- 1833920
- 3014937101
- 3007289746
- 3033509898
- 3009790163
- 3000170817
- 9611390
- 2531477
- 3005977257
- 3025603301
- 3009973699
- 3003541440
- 3002807561
- 3010370554
- 1833986
- 3015991317
- 3011390763
- 3015869493
- 9610612
- 3008868758
- 3012329926
- 3010665091
- 1824313
- 1835296
- 3016050940
- 3009380063
- 3014257776
- 3010097171
- 1530390
- 3003639920
- 3020282716
- 3013011598
- 1935627
- 3007993775
- 3012447612
- 8043792
- 2183449
- 1649518
- 2133928
- 9612277
- 1422634
- 3023852420
- 3009504230
- 3009941480
- 3030412764
- 3009882675
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#
summary
FDA Review#
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