Cleared Traditional

Alpha Vent PEEK Suture Anchor

K211502 · Stryker Endoscopy · Orthopedic
Aug 2021
Decision
82d
Days
Class 2
Risk

About This 510(k) Submission

K211502 is an FDA 510(k) clearance for the Alpha Vent PEEK Suture 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 August 4, 2021, 82 days after receiving the submission on May 14, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K211502 FDA.gov
FDA Decision Cleared SESE
Date Received May 14, 2021
Decision Date August 04, 2021
Days to Decision 82 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