FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Aevumed RAPID Suture Anchors
K Number: K223878
·
Decision Mar 17, 2023
Classifications
1
FEI Numbers
275
Registration Numbers
275
Same Product Code
593
Applicant Total
7
Review Days
80
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Aevumed RAPID Suture Anchors
- K Number
- K223878
- 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 27, 2022
- Decision Date
- March 17, 2023
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MBI), ordered by most recent decision date.
Dione PEEK Screw System
FDA 510(k)
FDA Class 2
·Orthopedic
Y-Knotless Flex Anchors
FDA 510(k)
FDA Class 2
·Orthopedic
Anchor with Fiber Wire and Disposable Inserter
FDA 510(k)
FDA Class 2
·Orthopedic
ArthroTAK Tendon Anchor Kit
FDA 510(k)
FDA Class 2
·Orthopedic
Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line
FDA 510(k)
FDA Class 2
·Orthopedic
Arthrex FiberTak Suture Anchor
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Aevumed, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K254306 | Aevumed FENIX Suture Anchor | Mar 4, 2026 | Substantially Equivalent |
| 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 |
| K222363 | Aevumed PHANTOM-LP Suture Anchors | Nov 28, 2022 | Substantially Equivalent |
| K180464 | AEVUMED PHANTOM Suture Anchors | May 31, 2018 | Substantially Equivalent |