Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Alpha Vent PEEK Suture Anchor

K-Number: K211502 · 2021-08-04

ApplicantStryker Endoscopy
Decision Date2021-08-04
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Alpha Vent PEEK Suture Anchor is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Endoscopy. It received FDA 510(k) clearance on 2021-08-04 under 510(k) number K211502. 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 Alpha Vent PEEK Suture Anchor?

Alpha Vent PEEK Suture Anchor is a medical device that received FDA 510(k) clearance on 2021-08-04. The listed applicant is Stryker Endoscopy. The 510(k) number is K211502.

When did Alpha Vent PEEK Suture Anchor receive FDA 510(k) clearance?

Alpha Vent PEEK Suture Anchor received FDA 510(k) clearance on 2021-08-04, under 510(k) number K211502.

Who is the listed applicant for Alpha Vent PEEK Suture Anchor?

The FDA 510(k) record lists Stryker Endoscopy as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Alpha Vent PEEK Suture Anchor?

The FDA product code for Alpha Vent PEEK Suture Anchor is MBI.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07631468PROspect Registry :Post Market Clinical Follow-up StudyRECRUITING

Other records listing Stryker Endoscopy as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262369AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved DownK253602Precision S 4K SinuscopeK261037780 nm SPY Portable Handheld Imaging (SPY-PHI) SystemK2601851688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with Advanced Imaging ModalityK260108L12 LED Light Source with AIMK254014Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control

View all 25 devices →

Related Devices (Code: MBI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262047Grappler Suture Anchor SystemParagon 28, Inc.K262369AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved DownStryker EndoscopyK261770Suture Button Repair SystemSkeletal Dynamics, Inc.K261632Thunderbolt SystemResponsive Arthroscopy, Inc.K261968Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981); Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one blue knotless and one black MINITAPE suture (72205982)Smith & Nephew, Inc.K260018Arthrex FiberButtonArthrex, Inc.

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.

↑