Cleared Traditional

AlphaVent Suture Anchors

K231093 · Stryker Endoscopy · Orthopedic
Aug 2023
Decision
134d
Days
Class 2
Risk

About This 510(k) Submission

K231093 is an FDA 510(k) clearance for the AlphaVent Suture Anchors, a Fastener, Fixation, Nondegradable, Soft Tissue (Class II — Special Controls, product code MBI), submitted by Stryker Endoscopy (San Jose, US). The FDA issued a Cleared decision on August 30, 2023, 134 days after receiving the submission on April 18, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K231093 FDA.gov
FDA Decision Cleared SESE
Date Received April 18, 2023
Decision Date August 30, 2023
Days to Decision 134 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code MBI — Fastener, Fixation, Nondegradable, Soft Tissue
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040