Cleared Traditional

AlphaVent Knotless SP PEEK Anchor

K233893 · Stryker Endoscopy · Orthopedic
Jan 2024
Decision
48d
Days
Class 2
Risk

About This 510(k) Submission

K233893 is an FDA 510(k) clearance for the AlphaVent Knotless SP PEEK Anchor, 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 January 25, 2024, 48 days after receiving the submission on December 8, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K233893 FDA.gov
FDA Decision Cleared SESE
Date Received December 08, 2023
Decision Date January 25, 2024
Days to Decision 48 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