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FDA 510(k)

Shadow Knotless All-Suture Anchors

K-Number: K233258 · 2023-10-23

ApplicantResponsive Arthroscopy, LLC
Decision Date2023-10-23
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Shadow Knotless All-Suture Anchors is a medical device manufactured by Responsive Arthroscopy, LLC. It received FDA 510(k) clearance on 2023-10-23 under approval number K233258. 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 Shadow Knotless All-Suture Anchors?

Shadow Knotless All-Suture Anchors is a medical device that received FDA 510(k) clearance on 2023-10-23. It is manufactured by Responsive Arthroscopy, LLC. The 510(k) number is K233258.

When was Shadow Knotless All-Suture Anchors approved by the FDA?

Shadow Knotless All-Suture Anchors received FDA 510(k) clearance on 2023-10-23, under approval number K233258.

What company makes Shadow Knotless All-Suture Anchors?

Shadow Knotless All-Suture Anchors is manufactured by Responsive Arthroscopy, LLC.

What is the FDA product code for Shadow Knotless All-Suture Anchors?

The FDA product code for Shadow Knotless All-Suture Anchors is MBI.

Related Clinical Trials

NCT04552119 Safety of Treatment of Shoulder Repair COMPLETED NCT06272201 Incisionless Suture Plications in a POSE2.0 Obesity Study NOT_YET_RECRUITING NCT07491276 Efficacy of Using Knotless Barbed Suture vs N-Butyl Cyanoacrylate Glue Tissue Adhesive for Closure of Intraoral Surgical Incisions ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 40868376 Correlation Analysis of Suture Anchor Pull-Out Strength with Cortical Bone Thickness and Cancellous Bone Density on a Finite Element Model. Bioengineering (Basel, Switzerland) (2025)

Other Devices by Responsive Arthroscopy, LLC

K180573Responsive Arthroscopy Interference Screw System K190446Responsive Arthroscopy Wedge Push-In Suture Anchors K181076Responsive Arthroscopy Wedge Push-In Suture Anchors K180951Responsive Arthroscopy Suture Anchor System K202569Responsive Arthroscopy Interference Screw System K202153Responsive Arthroscopy Suture Anchor System

View all 11 devices →

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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