510(k) K110990
- Device
- GSO ACP1 ANTERIOR CERVICAL PLATE SYSTEM
- Applicant
- GOLD STANDARD ORTHOPEDICS LLC
- 510(k) number
- K110990
- Product code
- KWQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2011-07-25
- Date received
- 2011-04-08
- 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
- JAMES RITTER
- Address
- 3415 N. Old Farm Rd. E. Warsaw IN US 46582 46582
FDA Registration Numbers#
- 2183946
- 3006272282
- 3010440433
- 3025603301
- 1000200989
- 2245304
- 3010365473
- 3012711663
- 1833506
- 3011489618
- 9615800
- 3010370554
- 9617297
- 3012491394
- 3004024955
- 1223434
- 3004961578
- 3012329926
- 3016084569
- 3022159082
- 9610612
- 1835831
- 3009169996
- 3014252644
- 3016112537
- 3006639944
- 1000517406
- 3015179588
- 3011127597
- 3005076207
- 3031261833
- 3009380063
- 3013422236
- 3006791286
- 1000432246
- 3010047454
- 2028632
- 3007923096
- 3014725904
- 3010143171
- 3004188066
- 3011015572
- 1833824
- 1644312
- 3036756245
- 1226544
- 3003477135
- 2032098
- 3009050824
- 1528646
- 2031093
- 3017936978
- 3016496998
- 3005819474
- 3007922509
- 3011221483
- 3019767615
- 3004049923
- 3003525643
- 3008455034
- 3005596514
- 3012131184
- 1000461041
- 2032112
- 3016676864
- 9611390
- 3007728266
- 3008992889
- 3011301313
- 3009189869
- 3000170817
- 3015941638
- 3008868758
- 3019837678
- 3009051471
- 1056553
- 3010363503
- 3003120897
- 1526534
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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