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FDA 510(k)

ZipE Knotless Tissue Repair and Attachment Devices

K-Number: K162429 · 2017-03-13

ApplicantZiptek, LLC
Decision Date2017-03-13
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ZipE Knotless Tissue Repair and Attachment Devices is the device name listed in this FDA 510(k) record. The listed applicant is Ziptek, LLC. It received FDA 510(k) clearance on 2017-03-13 under 510(k) number K162429. 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 ZipE Knotless Tissue Repair and Attachment Devices?

ZipE Knotless Tissue Repair and Attachment Devices is a medical device that received FDA 510(k) clearance on 2017-03-13. The listed applicant is Ziptek, LLC. The 510(k) number is K162429.

When did ZipE Knotless Tissue Repair and Attachment Devices receive FDA 510(k) clearance?

ZipE Knotless Tissue Repair and Attachment Devices received FDA 510(k) clearance on 2017-03-13, under 510(k) number K162429.

Who is the listed applicant for ZipE Knotless Tissue Repair and Attachment Devices?

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

What is the FDA product code for ZipE Knotless Tissue Repair and Attachment Devices?

The FDA product code for ZipE Knotless Tissue Repair and Attachment Devices 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.

NCT03985839Safety and Performance of MICRORAPTOR™ Suture Anchors in Shoulder and HipCOMPLETED

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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