510(k) K133911
- Device
- GENESYS SPINE ANTERIOR BUTTRESS PLATE SYSTEM
- Applicant
- GENESYS SPINE
- 510(k) number
- K133911
- Product code
- KWQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2014-09-03
- Date received
- 2013-12-23
- 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
- BRIAN J BERGERON
- Address
- 1250 Capital Of Texas Hwy. S. Bldg. Three, Suite 600 Austin TX US 78746 78746
FDA Registration Numbers#
- 3015869493
- 1833920
- 9681642
- 3015941638
- 1000517406
- 3015991317
- 3015179588
- 3003855635
- 1226544
- 3021945817
- 3009417901
- 3009217531
- 3005874553
- 3017435639
- 3016084569
- 1221053
- 9681465
- 3016237080
- 3009380063
- 3019837678
- 2531195
- 1223434
- 3010162973
- 3008285983
- 3011127597
- 3009189869
- 1835251
- 3007014520
- 3008526708
- 3010560653
- 3004176895
- 3006791286
- 3011277306
- 3009882675
- 3010120326
- 3012711663
- 3015398319
- 1644312
- 3037407500
- 9615800
- 3004499989
- 3012329926
- 1824199
- 3015709929
- 3025603301
- 3014257776
- 3007485169
- 3009957608
- 3012764194
- 3010120148
- 9611390
- 1834331
- 3007922509
- 3004638532
- 3010041993
- 3005497913
- 1225838
- 1828464
- 3019878714
- 3006017180
- 3009998573
- 3018094310
- 3006356043
- 2031966
- 9617297
- 3011530718
- 3004142400
- 3009971621
- 1720929
- 3014937101
- 3010041430
- 3009241418
- 3002976036
- 3010032903
- 3015869492
- 3010009693
- 3011577940
- 1833824
- 3004774118
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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