CYGNUS-C Standalone ACIF System
FDA 510(k) K222041 · GS Medical Co., Ltd.
510(k) numberK222041
Submission
- Device name
- CYGNUS-C Standalone ACIF System
- Applicant
- GS Medical Co., Ltd.
Cheongju-Si, KR - Received
- July 11, 2022
- Decision date
- February 9, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OVE – Intervertebral Fusion Device With Integrated Fixation, Cervical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3080
- Specialty
- Orthopedic
- Implant
- Yes
Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation.
Other 510(k)s with product code OVE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261882 | Pisces-SC Standalone Cervical Interbody SystemOVE · Traditional | Osseus Fusions Systems, LLC | 08/21/2026SE |
| K261451 | ZSAlign Cervical Interbody SystemOVE · Traditional | ZSFab, Inc. | 07/31/2026SE |
| K262094 | E3D-C Interbody SystemOVE · Special | Evolution Spine | 07/22/2026SE |
| K261279 | DeltaNEC Interbody SystemOVE · Traditional | Nexus Spine | 06/22/2026SE |
| K252982 | CONDUIT ZERO-P VA Secured Spacer SystemOVE · Traditional | Avalign Technologies, Inc. | 06/18/2026SE |
| K260036 | NeckTune 3D SA Cervical CageOVE · Traditional | Medyssey Co, Ltd. | 06/15/2026SE |
| K260660 | SABER-C SystemOVE · Traditional | Elevation Spine | 04/27/2026SE |
| K253213 | SAGI Cervical Cage SystemOVE · Traditional | ZheJiang Decans Medical Devices Co., Ltd. | 04/20/2026SE |
| K252774 | Uni-C Cervical Cage SystemOVE · Traditional | ZheJiang Decans Medical Devices Co., Ltd. | 04/15/2026SE |
| K260038 | E3D-C Interbody SystemOVE · Special | Evolution Spine | 02/04/2026SE |
More from Evolution Spine
| 510(k) | Device | Decision |
|---|---|---|
| K243073 | AnyPlus Navigated Instruments SystemOLO · Traditional | 12/06/2024SE |
| K241738 | PYXIS 3D Titanium Cervical Cage systemODP · Traditional | 08/20/2024SE |
| K240350 | AnyPlus II Spinal Fixation SystemNKB · Traditional | 04/03/2024SE |
| K231808 | QUASAR Standalone ACIF SystemOVE · Special | 07/20/2023SE |
| K223868 | PYXIS 3D Titanium Cage SystemMAX · Traditional | 04/26/2023SE |
| K221687 | Pegasus-X Expandable PLIF SystemMAX · Traditional | 07/27/2022SE |
| K211797 | TRACKER Plus Kyphoplasty SystemNDN · Traditional | 10/28/2021SE |
| K200592 | GS Medical AnyPlus PEEK Cage SystemODP · Traditional | 08/10/2020SE |
| K192335 | TRACKER Kyphoplasty SystemNDN · Traditional | 12/04/2019SE |
| K190170 | MVP Cervical Plate SystemKWQ · Traditional | 05/13/2019SE |
Questions and answers
When was CYGNUS-C Standalone ACIF System cleared by the FDA?
CYGNUS-C Standalone ACIF System (K222041) received a 510(k) decision of Substantially Equivalent on February 9, 2023, 213 days after the submission was received.
What is the product code of K222041?
The FDA product code is OVE – Intervertebral Fusion Device With Integrated Fixation, Cervical, a Class II (moderate risk) device regulated under 21 CFR 888.3080.