FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
Fixone Biocomposite Anchor
K Number: K230892
·
Decision Jun 9, 2023
Classifications
1
FEI Numbers
147
Registration Numbers
147
Same Product Code
219
Applicant Total
10
Review Days
70
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Basic Information
- Device Name
- Fixone Biocomposite Anchor
- K Number
- K230892
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Aju Pharm Co., Ltd.
- Date Received
- March 31, 2023
- Decision Date
- June 9, 2023
- Product Code
- MAI
- 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 |
|---|---|---|---|
| MAI | Fastener, Fixation, Biodegradable, Soft Tissue | FDA class 2 | Orthopedic |
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Other Clearances by Aju Pharm Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K233601 | Fixone Meniscal Repair | Aug 2, 2024 | Substantially Equivalent |
| K222423 | Fixone All Suture Anchor | Mar 23, 2023 | Substantially Equivalent |
| K203523 | Fixone hybrid knotless anchor | Dec 25, 2021 | Substantially Equivalent |
| K193497 | Fixone Biocomposite Interference Screw | Jan 5, 2021 | Substantially Equivalent |
| K192709 | Fixone All Suture Anchor | Dec 15, 2020 | Substantially Equivalent |
| K192484 | Fixone Biocomposite Anchor | Mar 11, 2020 | Substantially Equivalent |
| K192032 | Fixone Biocomposite Small Anchor | Mar 3, 2020 | Substantially Equivalent |
| K171299 | Fixone Biocomposite Anchor | Aug 24, 2017 | Substantially Equivalent |
| K162070 | JOINIX CANNULAR SYSTEM | Mar 16, 2017 | Substantially Equivalent |