Identifiers
- 510(k) Number
- K993373 FDA 510(k)
- FDA Product Code
- MAI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3030 FDA 510(k)
- Regulation Number
- 888.3030 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Rotorblade Suture Anchor is a fastener device used for soft tissue fixation in orthopedic procedures. It is designed to anchor sutures to bone, providing stability for soft tissue repairs.
This device is supplied as a single-use implant and is not MRI compatible. It is regulated under FDA 510(k) clearance with product code MAI and is classified as a Class II device for orthopedic use.
Frequently asked questions
What is the Rotorblade Suture Anchor used for?
The Rotorblade Suture Anchor is used for soft tissue fixation in orthopedic procedures, specifically to anchor sutures to bone and provide stability for soft tissue repairs.
Is the Rotorblade Suture Anchor reusable or single-use?
The Rotorblade Suture Anchor is supplied as a single-use implant and is not intended for reuse, ensuring sterility and preventing cross-contamination during surgical procedures.
Is the Rotorblade Suture Anchor MRI compatible?
The Rotorblade Suture Anchor is not MRI compatible, which should be considered when planning postoperative imaging for patients who have received this implant.
How is the Rotorblade Suture Anchor supplied and stored?
The Rotorblade Suture Anchor is supplied as a single-use implant; however, specific storage conditions such as temperature or humidity requirements are not detailed in the provided device data.
What regulatory pathway was used for the Rotorblade Suture Anchor?
The Rotorblade Suture Anchor received FDA 510(k) clearance, indicating it was found substantially equivalent to a legally marketed predicate device, and is classified as a Class II device under product code MAI.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K993373 | Class II | Active |
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Manufacturer
- Manufacturer
- Li Medical Technologies, Inc.
Sources (1)
- FDA 510(k) K993373 24 fields · synced Sep 23, 2026