510(k) K061147
- Device
- OPTERYX ANTERIOR CERVICAL PLATE SYSTEM
- Applicant
- INNOVASIS, INC.
- 510(k) number
- K061147
- Product code
- KWQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2006-06-30
- Date received
- 2006-04-25
- 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
- DAVID N MCKEAN
- Address
- 614 E 3900 S Salt Lake City UT US 84107 84107
FDA Registration Numbers#
- 3010097171
- 3001239363
- 1424263
- 3011530718
- 3015869492
- 3010560653
- 3011577940
- 3010440433
- 3007014520
- 9615800
- 3017521423
- 3010178296
- 3006755626
- 9614209
- 2532027
- 3009144915
- 3016676864
- 1833920
- 3010057495
- 3007289746
- 1835296
- 3011187779
- 3009217531
- 3012329926
- 3002976036
- 3005819474
- 1000517406
- 3009887475
- 3009051471
- 3009504230
- 1833986
- 3010049501
- 3009888740
- 1531174
- 3016112537
- 3009165919
- 3010462278
- 3011015572
- 3008455034
- 1223434
- 3006639944
- 3008110533
- 1720929
- 1417485
- 3010120339
- 3017435639
- 9611813
- 3010663372
- 1828288
- 3009790163
- 3008526708
- 2648623
- 3034676720
- 8043792
- 1226544
- 9612277
- 3009957608
- 3005497913
- 3009106092
- 1224360
- 3012131184
- 3015399803
- 3004464325
- 3003639920
- 3010370554
- 9681642
- 3010120135
- 3031240334
- 3011874600
- 3015179588
- 3014725904
- 9617544
- 3000170817
- 3012491394
- 3016443334
- 3000270450
- 1526439
- 3020282716
- 3007923096
Source Documents#
Other 510(k) Records For Product Code KWQ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K243904 | Elegance® Anterior Cervical plate | Clariance | 2025-01-14 |
Legacy Summary#
summary
FDA Review#
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