Rotium Bioresorbable Wick
FDA 510(k) clearance K201414 · decided 2020-06-25
Clearance details
- K-number
- K201414
- Device name
- Rotium Bioresorbable Wick
- Applicant
- Nanofiber Solutions, LLC
- Decision
- Substantially Equivalent
- Date received
- 2020-05-29
- Decision date
- 2020-06-25
- Days to decision
- 27 days
- Clearance type
- Special
- Product code
- MAI
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Hilliard, OH, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
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| SF Push-in Anchor (K260294) | Surgical Fusion Technologies GmbH | 2026-03-27 |
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| Biosteon® Screw (K251680) | Biocomposites, Ltd. | 2026-02-17 |
| BioBrace® Extra-Articular Ligament Augmentation Kit (K252946) | Conmed Corporation | 2025-10-15 |
| OSSIOfiber® Interference Screw (K252022) | OSSIO , Ltd. | 2025-08-19 |
| OSSIOfiber® Suture Anchor (K251309) | OSSIO , Ltd. | 2025-05-27 |
| Knotilus+ Biocomposite Knotless Anchor (K250544) | Stryker Endoscopy | 2025-05-23 |
| Stryker AlphaVent™ Knotless SP Biocomposite Anchor (K250528) | Stryker Endoscopy | 2025-05-21 |
| OSSIOfiber® Suture Anchor 2.5-3.5 mm (K243760) | OSSIO , Ltd. | 2025-04-03 |
| Arthrex 4.75 mm Double Loaded Knotless Corkscrew Suture Anchor (K250526) | Arthrex, Inc. | 2025-03-14 |
Recalls involving this device
No recalls on record reference this clearance.