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FDA 510(k)

AlphaVent Knotless SP PEEK Anchor

K-Number: K233893 · 2024-01-25

ApplicantStryker Endoscopy
Decision Date2024-01-25
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AlphaVent Knotless SP PEEK Anchor is a medical device manufactured by Stryker Endoscopy. It received FDA 510(k) clearance on 2024-01-25 under approval number K233893. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AlphaVent Knotless SP PEEK Anchor?

AlphaVent Knotless SP PEEK Anchor is a medical device that received FDA 510(k) clearance on 2024-01-25. It is manufactured by Stryker Endoscopy. The 510(k) number is K233893.

When was AlphaVent Knotless SP PEEK Anchor approved by the FDA?

AlphaVent Knotless SP PEEK Anchor received FDA 510(k) clearance on 2024-01-25, under approval number K233893.

What company makes AlphaVent Knotless SP PEEK Anchor?

AlphaVent Knotless SP PEEK Anchor is manufactured by Stryker Endoscopy.

What is the FDA product code for AlphaVent Knotless SP PEEK Anchor?

The FDA product code for AlphaVent Knotless SP PEEK Anchor is MBI.

Other Devices by Stryker Endoscopy

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Related Devices (Code: MBI)

K163034SUTUREFIX Curved Suture AnchorSmith and Nephew, Inc. K162198GFS UltimateParcus Medical, LLC K162386KATOR Suture AnchorKator, LLC K161033AFX™ Femoral Implant With InserterCayenne Medical, Inc. K160996Dunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mmDunamis, LLC K161001MILAGRO ADVANCE PEEK Interference ScrewMedos International SARL

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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