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FDA 510(k)

Paradigm All-Suture Anchor 1.8mm, White/Black #2

K-Number: K190333 · 2019-03-18

ApplicantConmed Corporation
Decision Date2019-03-18
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Paradigm All-Suture Anchor 1.8mm, White/Black #2 is the device name listed in this FDA 510(k) record. The listed applicant is Conmed Corporation. It received FDA 510(k) clearance on 2019-03-18 under 510(k) number K190333. 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 Paradigm All-Suture Anchor 1.8mm, White/Black #2?

Paradigm All-Suture Anchor 1.8mm, White/Black #2 is a medical device that received FDA 510(k) clearance on 2019-03-18. The listed applicant is Conmed Corporation. The 510(k) number is K190333.

When did Paradigm All-Suture Anchor 1.8mm, White/Black #2 receive FDA 510(k) clearance?

Paradigm All-Suture Anchor 1.8mm, White/Black #2 received FDA 510(k) clearance on 2019-03-18, under 510(k) number K190333.

Who is the listed applicant for Paradigm All-Suture Anchor 1.8mm, White/Black #2?

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 Paradigm All-Suture Anchor 1.8mm, White/Black #2?

The FDA product code for Paradigm All-Suture Anchor 1.8mm, White/Black #2 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 AnchorsK253763Y-Knotless™ Flex AnchorsK252946BioBrace® Extra-Articular Ligament Augmentation KitK251530CONMED Argo Knotless® AnchorK250395BioBrace ® RC Delivery SystemK244025Argo Knotless GENESYS Anchor

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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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