FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
QUASAR Standalone ACIF System
K Number: K231808
·
Decision Jul 20, 2023
Classifications
1
FEI Numbers
230
Registration Numbers
230
Same Product Code
161
Applicant Total
18
Review Days
30
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Basic Information
- Device Name
- QUASAR Standalone ACIF System
- K Number
- K231808
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- GS Medical Co., Ltd.
- Date Received
- June 20, 2023
- Decision Date
- July 20, 2023
- Product Code
- OVE
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | FDA class 2 | Orthopedic |
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Other Clearances by GS Medical Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K243073 | AnyPlus Navigated Instruments System | Dec 6, 2024 | Substantially Equivalent |
| K241738 | PYXIS 3D Titanium Cervical Cage system | Aug 20, 2024 | Substantially Equivalent |
| K240350 | AnyPlus II Spinal Fixation System | Apr 3, 2024 | Substantially Equivalent |
| K223868 | PYXIS 3D Titanium Cage System | Apr 26, 2023 | Substantially Equivalent |
| K222041 | CYGNUS-C Standalone ACIF System | Feb 9, 2023 | Substantially Equivalent |
| K221687 | Pegasus-X Expandable PLIF System | Jul 27, 2022 | Substantially Equivalent |
| K211797 | TRACKER Plus Kyphoplasty System | Oct 28, 2021 | Substantially Equivalent |
| K200592 | GS Medical AnyPlus PEEK Cage System | Aug 10, 2020 | Substantially Equivalent |
| K192335 | TRACKER Kyphoplasty System | Dec 4, 2019 | Substantially Equivalent |
| K190170 | MVP Cervical Plate System | May 13, 2019 | Substantially Equivalent |