510(k) K152239
- Device
- Zero-P Natural Plate System
- Applicant
- Synthes (USA), LLC
- 510(k) number
- K152239
- Product code
- KWQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-12-02
- Date received
- 2015-08-10
- 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
- Beth Becotte
- Address
- 1051 Synthes Ave. Monument CO US 80132 80132
FDA Registration Numbers#
- 3003935342
- 3012131184
- 1223434
- 3011221483
- 1722511
- 3010160527
- 3009882675
- 3008455034
- 3014938863
- 3011530718
- 3010068573
- 3016678045
- 3011127597
- 3006017180
- 3009173317
- 3030412764
- 3003597504
- 3011577940
- 3007993775
- 3015941638
- 9614209
- 3007675554
- 3006378738
- 3007539489
- 3015877656
- 3005596514
- 3010123206
- 3010370500
- 3008992889
- 3013422238
- 3003639920
- 3004719693
- 3013055499
- 2183449
- 3010866843
- 3013011598
- 3007441485
- 3012329926
- 3010041430
- 3011874600
- 3015831087
- 3013548554
- 3002976036
- 2134470
- 3009165919
- 1720929
- 1526534
- 9611813
- 3019837678
- 1828288
- 9617297
- 3009050824
- 1834331
- 1056553
- 3014257776
- 3009888740
- 3010531060
- 1000200989
- 9681642
- 3014725904
- 3008110533
- 3009106092
- 3011277306
- 3004638532
- 1225838
- 3008812560
- 3008850074
- 1935627
- 3004499989
- 3008285983
- 3009959868
- 3016438694
- 3033509898
- 1225675
- 3010370880
- 3012599928
- 3007344102
- 3004635447
- 3004049923
- 3004176895
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#
summary
FDA Review#
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