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FDA 510(k)

ICONN Revolution Knotless Suture Anchor

K-Number: K182264 · 2018-10-19

ApplicantIconn Orthopedics, LLC
Decision Date2018-10-19
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ICONN Revolution Knotless Suture Anchor is the device name listed in this FDA 510(k) record. The listed applicant is Iconn Orthopedics, LLC. It received FDA 510(k) clearance on 2018-10-19 under 510(k) number K182264. 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 ICONN Revolution Knotless Suture Anchor?

ICONN Revolution Knotless Suture Anchor is a medical device that received FDA 510(k) clearance on 2018-10-19. The listed applicant is Iconn Orthopedics, LLC. The 510(k) number is K182264.

When did ICONN Revolution Knotless Suture Anchor receive FDA 510(k) clearance?

ICONN Revolution Knotless Suture Anchor received FDA 510(k) clearance on 2018-10-19, under 510(k) number K182264.

Who is the listed applicant for ICONN Revolution Knotless Suture Anchor?

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

What is the FDA product code for ICONN Revolution Knotless Suture Anchor?

The FDA product code for ICONN Revolution Knotless 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.

NCT04552119Safety of Treatment of Shoulder RepairCOMPLETED

Other records listing Iconn Orthopedics, 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.

K180670ICONN Campbell Interference ScrewK181680ICONN Answer II Suture AnchorK172491ICONN Square 2.5MM Suture Anchor

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.

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