FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HS Fiber
K Number: K202242
·
Decision Sep 10, 2020
Classifications
1
FEI Numbers
242
Registration Numbers
242
Same Product Code
173
Applicant Total
11
Review Days
31
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Basic Information
- Device Name
- HS Fiber
- K Number
- K202242
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 878.5000
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Riverpoint Medical, LLC
- Date Received
- August 10, 2020
- Decision Date
- September 10, 2020
- Product Code
- GAT
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | FDA class 2 | General, Plastic Surgery |
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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 |
| K243988 | RootMend MRR | Mar 20, 2025 | 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 |