510(k) K141500
- Device
- OPTIO-C ANTERIOR CERVICAL SYSTEM
- Applicant
- ZIMMER SPINE, INC.
- 510(k) number
- K141500
- Product code
- KWQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2014-09-23
- Date received
- 2014-06-06
- 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
- DONNA M SEMLAK
- Address
- 7375 Bush Lake Rd. Minneapolis MN US 55439 55439
FDA Registration Numbers#
- 9617297
- 1226544
- 3007993775
- 3007485169
- 3006846753
- 3011221483
- 3010866843
- 3009554293
- 3005819474
- 3015991317
- 3015869121
- 3043543260
- 3010370880
- 2531477
- 3036756245
- 3006404019
- 3034676720
- 3011127597
- 1828288
- 3011556898
- 3015941638
- 3024999441
- 3009756327
- 3016112537
- 3008526708
- 3006217744
- 3016443334
- 3010120326
- 3004893332
- 2531195
- 2530808
- 2028632
- 3015869492
- 3010041993
- 1043214
- 3010120135
- 3008110533
- 3009169872
- 3010363503
- 3007289746
- 3010665091
- 2032112
- 3017565094
- 3031240334
- 3014252644
- 1644312
- 1526439
- 1527105
- 1221763
- 3004774118
- 3008791302
- 2029275
- 9681465
- 3010041430
- 1832228
- 3009504230
- 1424263
- 3003898943
- 9615800
- 3000170817
- 3003935342
- 3009173317
- 3012711663
- 3018210489
- 2032093
- 3025457095
- 3015179588
- 3010509633
- 3020282716
- 2647346
- 3011390763
- 9610612
- 1000432246
- 3017521423
- 3008868758
- 8043792
- 3008262872
- 3005180920
- 3005706667
- 1225838
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#
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