QUASAR Standalone ACIF System
FDA 510(k) K231808 · GS Medical Co., Ltd.
510(k) numberK231808
Submission
- Device name
- QUASAR Standalone ACIF System
- Applicant
- GS Medical Co., Ltd.
Cheongju-Si, KR - Received
- June 20, 2023
- Decision date
- July 20, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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.
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| K260038 | E3D-C Interbody SystemOVE · Special | Evolution Spine | 02/04/2026SE |
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| K211797 | TRACKER Plus Kyphoplasty SystemNDN · Traditional | 10/28/2021SE |
| K200592 | GS Medical AnyPlus PEEK Cage SystemODP · Traditional | 08/10/2020SE |
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Questions and answers
When was QUASAR Standalone ACIF System cleared by the FDA?
QUASAR Standalone ACIF System (K231808) received a 510(k) decision of Substantially Equivalent on July 20, 2023, 30 days after the submission was received.
What is the product code of K231808?
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.