510(k) K070922
- Device
- MODIFICATION TO SPINAL USA VBR SYSTEM
- Applicant
- SPINAL USA
- 510(k) number
- K070922
- Product code
- KWQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2007-09-19
- Date received
- 2007-04-02
- 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
- JEFFREY JOHNSON
- Address
- 644 Lakeland E. Dr., Suite A Flowood MS US 39232 39232
FDA Registration Numbers#
- 2183449
- 3012491394
- 2183946
- 3009973699
- 2531195
- 3009790163
- 3009760038
- 3012120772
- 1834379
- 1833506
- 9612277
- 3006110997
- 1526534
- 3009971621
- 1030489
- 3011302058
- 3004464325
- 3008868758
- 3010531060
- 3003541440
- 3010120104
- 3010120148
- 3016050940
- 3013422238
- 1220477
- 1835444
- 1417485
- 3015941638
- 3008285983
- 3012447612
- 3008992889
- 3010665091
- 3011556898
- 1828288
- 3015869121
- 3005977257
- 3010197224
- 3010287685
- 1450662
- 3006404071
- 3019837678
- 3016237080
- 3009144915
- 3011301313
- 3003639920
- 9610612
- 1649379
- 3034676720
- 3019767615
- 3010047454
- 2031966
- 3002976036
- 3004635447
- 3013011598
- 3009189869
- 1833824
- 3005144609
- 1531174
- 3010120326
- 3004788213
- 3010041499
- 3015869492
- 3008583793
- 1824199
- 1424263
- 3013548554
- 3010123206
- 1834331
- 1720929
- 2134285
- 9617297
- 3017565094
- 3017435639
- 3009165919
- 3009169996
- 2028632
- 3004748528
- 3003898943
- 3011874600
- 3015179588
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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