FDA 510(k)

TruShot with Y-Knot All-Suture Anchor

K-Number: K182446 · 2018-12-19

Decision Date2018-12-19

Product CodeMBI

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

TruShot with Y-Knot All-Suture Anchor is the device name listed in this FDA 510(k) record. The listed applicant is Conmed Corporation. It received FDA 510(k) clearance on 2018-12-19 under 510(k) number K182446. 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 TruShot with Y-Knot All-Suture Anchor?

TruShot with Y-Knot All-Suture Anchor is a medical device that received FDA 510(k) clearance on 2018-12-19. The listed applicant is Conmed Corporation. The 510(k) number is K182446.

When did TruShot with Y-Knot All-Suture Anchor receive FDA 510(k) clearance?

TruShot with Y-Knot All-Suture Anchor received FDA 510(k) clearance on 2018-12-19, under 510(k) number K182446.

Who is the listed applicant for TruShot with Y-Knot All-Suture Anchor?

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

What is the FDA product code for TruShot with Y-Knot All-Suture Anchor?

The FDA product code for TruShot with Y-Knot All-Suture Anchor is MBI.

Other records listing Conmed Corporation 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.

K261363Y-Knotless™ Flex Anchors K253763Y-Knotless™ Flex Anchors K252946BioBrace® Extra-Articular Ligament Augmentation Kit K251530CONMED Argo Knotless® Anchor K250395BioBrace ® RC Delivery System K244025Argo Knotless GENESYS Anchor

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Related Devices (Code: MBI)

K262047Grappler Suture Anchor SystemParagon 28, Inc.K262369AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved DownStryker Endoscopy K261770Suture 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.