510(k) K181846
- Device
- ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP Anterior Cervical Plate System, XTEND Anterior Cervical Plate System, UNIFY Dynamic Anterior Cervical Plate System, CITADEL Anterior Lumbar Plate System, TRUSS Thor
- Applicant
- Globus Medical Inc.
- 510(k) number
- K181846
- Product code
- KWQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-11-06
- Date received
- 2018-07-11
- 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
- Lori Burns
- Address
- 2560 General Armistead Ave. Audubon PA US 19403 19403
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#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases