510(k) K841189
- Device
- OEC/REZAIAN SPINAL FIXATOR
- Applicant
- ORTHOPEDIC EQUIPMENT CO., INC.
- 510(k) number
- K841189
- Product code
- KWQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-05-16
- Date received
- 1984-03-20
- Regulation
- 888.3060
- Classification name
- Appliance, Fixation, Spinal Intervertebral Body
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 4221 Richmond Rd., NW Walker MI US 49534 49534
FDA Registration Numbers#
- 3010057495
- 3010370500
- 3009957608
- 3006791286
- 1528646
- 1835831
- 1834379
- 3015179588
- 3025603301
- 3000203391
- 3015426608
- 3005641619
- 3011181154
- 3015398319
- 3017565094
- 3009826895
- 3012764194
- 3006082533
- 3009882675
- 1833986
- 3013011598
- 3010120135
- 2530808
- 3011127597
- 3012994232
- 3012491394
- 3005823819
- 9611813
- 9612277
- 3018210489
- 3009973505
- 3009049161
- 3007289746
- 3007345964
- 1424263
- 3021945817
- 9615128
- 3014252644
- 3004774118
- 2648623
- 3013422238
- 3009169996
- 3036756245
- 1530390
- 3016438694
- 3031240334
- 3008285983
- 3004941535
- 3006404071
- 3010041993
- 3014273424
- 3004024955
- 1644312
- 3009704301
- 3009998573
- 3006639944
- 3004788213
- 1057425
- 3009165919
- 1220477
- 3015860552
- 2032112
- 9617544
- 1224360
- 2032098
- 3013055499
- 2183946
- 3007728266
- 3015991317
- 1834331
- 8010468
- 3010123256
- 3005226664
- 3017597868
- 3014938863
- 3016237080
- 9681642
- 3013422236
- 1832228
- 3012429289
Source Documents#
510(k) summary PDF not indicated by FDA
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#
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FDA Review#
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