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FDA 510(k)

CrossFT Knotless Biocomposite Suture Anchor with Disposable Driver

K-Number: K170501 · 2017-03-17

ApplicantConmed Corporation
Decision Date2017-03-17
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CrossFT Knotless Biocomposite Suture Anchor with Disposable Driver is the device name listed in this FDA 510(k) record. The listed applicant is Conmed Corporation. It received FDA 510(k) clearance on 2017-03-17 under 510(k) number K170501. The device is classified under product code MAI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CrossFT Knotless Biocomposite Suture Anchor with Disposable Driver?

CrossFT Knotless Biocomposite Suture Anchor with Disposable Driver is a medical device that received FDA 510(k) clearance on 2017-03-17. The listed applicant is Conmed Corporation. The 510(k) number is K170501.

When did CrossFT Knotless Biocomposite Suture Anchor with Disposable Driver receive FDA 510(k) clearance?

CrossFT Knotless Biocomposite Suture Anchor with Disposable Driver received FDA 510(k) clearance on 2017-03-17, under 510(k) number K170501.

Who is the listed applicant for CrossFT Knotless Biocomposite Suture Anchor with Disposable Driver?

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 CrossFT Knotless Biocomposite Suture Anchor with Disposable Driver?

The FDA product code for CrossFT Knotless Biocomposite Suture Anchor with Disposable Driver is MAI.

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 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: MAI)

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.

K262357Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc.K253931Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc.K260294SF Push-in AnchorSurgical Fusion Technologies GmbHK254055OSSIOfiber® Suture AnchorOSSIO , Ltd.K251680Biosteon® ScrewBiocomposites, Ltd.K252946BioBrace® Extra-Articular Ligament Augmentation KitConmed Corporation

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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