FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Aevumed FENIX Suture Anchor
K Number: K254306
·
Decision Mar 4, 2026
Classifications
1
FEI Numbers
275
Registration Numbers
275
Same Product Code
593
Applicant Total
7
Review Days
63
Basic Information
- Device Name
- Aevumed FENIX Suture Anchor
- K Number
- K254306
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Aevumed, Inc.
- Date Received
- December 31, 2025
- Decision Date
- March 4, 2026
- Product Code
- MBI
- 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 |
|---|---|---|---|
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | FDA class 2 | Orthopedic |
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Other Clearances by Aevumed, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K260004 | Aevumed PROTEKT Suture Anchor | Jan 28, 2026 | Substantially Equivalent |
| K253040 | Aevumed FASE Suture Anchor | Oct 21, 2025 | Substantially Equivalent |
| K242895 | Aevumed PHANTOM Suture Anchors | Aug 6, 2025 | Substantially Equivalent |
| K223878 | Aevumed RAPID Suture Anchors | Mar 17, 2023 | Substantially Equivalent |
| K222363 | Aevumed PHANTOM-LP Suture Anchors | Nov 28, 2022 | Substantially Equivalent |
| K180464 | AEVUMED PHANTOM Suture Anchors | May 31, 2018 | Substantially Equivalent |