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FDA 510(k)

Flip Button Suture Anchor

K-Number: K153585 · 2016-05-05

ApplicantFirst Ray, LLC
Decision Date2016-05-05
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Flip Button Suture Anchor is the device name listed in this FDA 510(k) record. The listed applicant is First Ray, LLC. It received FDA 510(k) clearance on 2016-05-05 under 510(k) 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. The listed applicant is First Ray, LLC. The 510(k) number is K153585.

When did Flip Button Suture Anchor receive FDA 510(k) clearance?

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

Who is the listed applicant for Flip Button Suture Anchor?

The FDA 510(k) record lists First Ray, LLC as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing First Ray, LLC 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.

K163440Stealth Staple SystemK153638Bicortical Fixation Screw & Washer Nut SystemK153622First Ray Internal Bone Staple System

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

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

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