510(k) K222041
- Device
- CYGNUS-C Standalone ACIF System
- Applicant
- GS Medical Co., Ltd.
- 510(k) number
- K222041
- Product code
- OVE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-02-09
- Date received
- 2022-07-11
- Regulation
- 888.3080
- Classification name
- Intervertebral Fusion Device With Integrated Fixation, Cervical
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Applicant Contact
- Contact
- Sam Camp
- Address
- 90, Osongsaengmyeong 4-Ro, Osong-Eup, Heungdeok-Gu, Cheongju-Si KR 28161 28161
FDA Registration Numbers
- 1423662
- 1450662
- 2133928
- 3005180920
- 3012131184
- 3013820501
- 3009241418
- 2530808
- 3006404071
- 3009394448
- 3010197239
- 2134470
- 3010057495
- 1000461041
- 3014655115
- 2031917
- 3011127597
- 3010041430
- 3007210720
- 2183946
- 3023852420
- 1834331
- 2032098
- 3000203391
- 1824199
- 3015212339
- 3009962553
- 3010197224
- 3005325790
- 1833920
- 3025603301
- 3003855635
- 3002807112
- 3016112537
- 3004142400
- 3009504230
- 2028632
- 3016460869
- 9610612
- 3000170817
- 3010032903
- 1319660
- 2532027
- 3010120104
- 3005819474
- 3017521423
- 3010162973
- 3013961579
- 3004635447
- 1424434
- 3012428435
- 9611390
- 3016443334
- 3004153896
- 3009756327
- 3014680795
- 3005031160
- 3025602479
- 3010863450
- 3019767615
- 3015216945
- 3016438694
- 8020776
- 3009973336
- 3008110533
- 3012028003
- 3010097171
- 9615800
- 3006128100
- 3019837678
- 3015398319
- 3005739886
- 3017936978
- 1649518
- 9681465
- 1030489
- 3007604895
- 2032093
- 3017528621
- 3009217531
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| Primary DI | Brand | Company | Published |
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| 08809885711764 | GluOn-IF Stand-alone ACIF Cage System | GS Medical Co., Ltd. | 2023-02-17 |
| 08809885711771 | GluOn-IF Stand-alone ACIF Cage System | GS Medical Co., Ltd. | 2023-02-17 |
| 08809885711788 | GluOn-IF Stand-alone ACIF Cage System | GS Medical Co., Ltd. | 2023-02-17 |
| 08809885711795 | GluOn-IF Stand-alone ACIF Cage System | GS Medical Co., Ltd. | 2023-02-17 |
| 08809885711801 | GluOn-IF Stand-alone ACIF Cage System | GS Medical Co., Ltd. | 2023-02-17 |
| 08809885711818 | GluOn-IF Stand-alone ACIF Cage System | GS Medical Co., Ltd. | 2023-02-17 |
| 08809885711825 | GluOn-IF Stand-alone ACIF Cage System | GS Medical Co., Ltd. | 2023-02-17 |
| 08809885711832 | GluOn-IF Stand-alone ACIF Cage System | GS Medical Co., Ltd. | 2023-02-17 |
| 08809885711757 | GluOn-IF Stand-alone ACIF Cage System | GS Medical Co., Ltd. | 2023-02-17 |
| 08809885711740 | GluOn-IF Stand-alone ACIF Cage System | GS Medical Co., Ltd. | 2023-02-17 |
| 08809885711665 | GluOn-IF Stand-alone ACIF Cage System | GS Medical Co., Ltd. | 2023-02-17 |
| 08809885711627 | GluOn-IF Stand-alone ACIF Cage System | GS Medical Co., Ltd. | 2023-02-17 |
| 08809885711603 | GluOn-IF Stand-alone ACIF Cage System | GS Medical Co., Ltd. | 2023-02-17 |
| 08809885711658 | GluOn-IF Stand-alone ACIF Cage System | GS Medical Co., Ltd. | 2023-02-17 |
| 08809885711733 | GluOn-IF Stand-alone ACIF Cage System | GS Medical Co., Ltd. | 2023-02-17 |
| 08809885711719 | GluOn-IF Stand-alone ACIF Cage System | GS Medical Co., Ltd. | 2023-02-17 |
| 08809885711672 | GluOn-IF Stand-alone ACIF Cage System | GS Medical Co., Ltd. | 2023-02-17 |
| 08809885711597 | GluOn-IF Stand-alone ACIF Cage System | GS Medical Co., Ltd. | 2023-02-17 |
| 08809885711559 | GluOn-IF Stand-alone ACIF Cage System | GS Medical Co., Ltd. | 2023-02-17 |
| 08809885710231 | GluOn-IF Stand-alone ACIF Cage System | GS Medical Co., Ltd. | 2023-02-17 |
| 08809885711580 | GluOn-IF Stand-alone ACIF Cage System | GS Medical Co., Ltd. | 2023-02-17 |
| 08809885711726 | GluOn-IF Stand-alone ACIF Cage System | GS Medical Co., Ltd. | 2023-02-17 |
| 08809885711634 | GluOn-IF Stand-alone ACIF Cage System | GS Medical Co., Ltd. | 2023-02-17 |
| 08809885711610 | GluOn-IF Stand-alone ACIF Cage System | GS Medical Co., Ltd. | 2023-02-17 |
| 08809885711702 | GluOn-IF Stand-alone ACIF Cage System | GS Medical Co., Ltd. | 2023-02-17 |
| 08809885711566 | GluOn-IF Stand-alone ACIF Cage System | GS Medical Co., Ltd. | 2023-02-17 |
| 08809885711542 | GluOn-IF Stand-alone ACIF Cage System | GS Medical Co., Ltd. | 2023-02-17 |
| 08809885711689 | GluOn-IF Stand-alone ACIF Cage System | GS Medical Co., Ltd. | 2023-02-17 |
| 08809885711641 | GluOn-IF Stand-alone ACIF Cage System | GS Medical Co., Ltd. | 2023-02-17 |
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| K253200 | Cervical Spine Truss System - Stand Alone (CSTS-SA) | 4Web Medical, Inc. | 2025-12-11 |
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| K251431 | FIX-C PEEK ACIF SA System | Jeil Medical Corporation | 2025-06-27 |
| K251117 | Cervical Spine Truss System (CSTS) | 4Web Medical | 2025-04-25 |
| K242928 | Tesera-k SC System | Kyocera Medical Technologies, Inc. | 2025-04-10 |
| K243188 | CYLOX® ST | Signus Medizintechnik GmbH | 2025-02-11 |
| K242483 | Genesys Spine AIS-C II Cervical Interbody Fusion System | Genesys Spine | 2025-02-07 |
| K242517 | ProAM ACDF System | Pro Surgical, Inc. | 2024-11-20 |