FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RootMend MRR
K Number: K243988
·
Decision Mar 20, 2025
Classifications
1
FEI Numbers
275
Registration Numbers
275
Same Product Code
593
Applicant Total
11
Review Days
84
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Basic Information
- Device Name
- RootMend MRR
- K Number
- K243988
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Riverpoint Medical, LLC
- Date Received
- December 26, 2024
- Decision Date
- March 20, 2025
- 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 Riverpoint Medical, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K253693 | Strut Suture; No-Tie Button | Mar 11, 2026 | Substantially Equivalent |
| K253695 | LigaMend | Feb 27, 2026 | Substantially Equivalent |
| K242494 | OsseoFit Interfacing Anchor; OsseoFit Bone Tunnel Construct | Nov 26, 2024 | Substantially Equivalent |
| K232411 | JuggerKnot Soft Anchor OC | Oct 6, 2023 | Substantially Equivalent |
| K231078 | All-Suture Anchor | Oct 5, 2023 | Substantially Equivalent |
| K231278 | Knotless Suture Anchor | Aug 1, 2023 | Substantially Equivalent |
| K220765 | HS Fiber Cerclage | Jul 26, 2023 | Substantially Equivalent |
| K231128 | JuggerKnot Soft Anchor | May 17, 2023 | Substantially Equivalent |
| K230212 | OrthoButton AL | Feb 23, 2023 | Substantially Equivalent |
| K202242 | HS Fiber | Sep 10, 2020 | Substantially Equivalent |