Alpha Vent PEEK Suture Anchor
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K211502 FDA 510(k)
- FDA Product Code
- MBI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3040 FDA 510(k)
- Regulation Number
- 888.3040 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Alpha Vent PEEK Suture Anchor is a suture anchor device made of PEEK material. It is designed for use in orthopedic procedures to attach sutures to bone.
The device is supplied in multiple sizes and configurations, including three anchor sizes and various suture options. It is intended for professional use and has received FDA 510(k) clearance under product code MBI.
Frequently asked questions
What is the Alpha Vent PEEK Suture Anchor used for?
The Alpha Vent PEEK Suture Anchor is designed for use in orthopedic procedures to attach sutures to bone, providing secure fixation for soft tissue repair in surgeries such as rotator cuff or labral reconstructions.
How is the Alpha Vent PEEK Suture Anchor supplied and what sizes are available?
The device is supplied in multiple sizes and configurations, including three anchor sizes and various suture options, allowing surgeons to select the appropriate size and suture type based on the specific anatomical site and surgical technique required.
Is the Alpha Vent PEEK Suture Anchor sterile and intended for single use?
While the device data does not explicitly state sterility or single-use status, as a professionally used implantable suture anchor with FDA 510(k) clearance, it is typically supplied sterile and intended for single-use implantation to ensure patient safety and prevent cross-contamination.
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. Sources consulted: PDF AlphaVent - Stryker, AlphaVent Biocomposite anchor for sports medicine repairs - Stryker, New STRYKER 3910-947-022 AlphaVent PEEK Suture Anchor (4.75mm, 2 ..., PDF AlphaVent - stryker-prod65.adobecqms.net
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K211502 | Class II | Active |
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Manufacturer
- Manufacturer
- Stryker Endoscopy
Sources (1)
- FDA 510(k) K211502 24 fields · synced Sep 26, 2026