FDA 510(k)

Flip Button Suture Anchor

K-Number: K153585 · 2016-05-05

Decision Date2016-05-05

Product CodeMBI

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Flip Button Suture Anchor is a medical device manufactured by First Ray, LLC. It received FDA 510(k) clearance on 2016-05-05 under approval number K153585. 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 Flip Button Suture Anchor?

Flip Button Suture Anchor is a medical device that received FDA 510(k) clearance on 2016-05-05. It is manufactured by First Ray, LLC. The 510(k) number is K153585.

When was Flip Button Suture Anchor approved by the FDA?

Flip Button Suture Anchor received FDA 510(k) clearance on 2016-05-05, under approval number K153585.

What company makes Flip Button Suture Anchor?

Flip Button Suture Anchor is manufactured by First Ray, LLC.

What is the FDA product code for Flip Button Suture Anchor?

The FDA product code for Flip Button Suture Anchor is MBI.

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 First Ray, LLC

K153638Bicortical Fixation Screw & Washer Nut System K153622First Ray Internal Bone Staple System K163440Stealth Staple System

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.