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FDA 510(k)

Xtreme-Loop

K-Number: K191053 · 2019-07-17

ApplicantXiros, Ltd.
Decision Date2019-07-17
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Xtreme-Loop is the device name listed in this FDA 510(k) record. The listed applicant is Xiros, Ltd.. It received FDA 510(k) clearance on 2019-07-17 under 510(k) number K191053. 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 Xtreme-Loop?

Xtreme-Loop is a medical device that received FDA 510(k) clearance on 2019-07-17. The listed applicant is Xiros, Ltd.. The 510(k) number is K191053.

When did Xtreme-Loop receive FDA 510(k) clearance?

Xtreme-Loop received FDA 510(k) clearance on 2019-07-17, under 510(k) number K191053.

Who is the listed applicant for Xtreme-Loop?

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

What is the FDA product code for Xtreme-Loop?

The FDA product code for Xtreme-Loop is MBI.

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Other records listing Xiros, Ltd. as applicant

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Related Devices (Code: MBI)

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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.

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