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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 a medical device manufactured by Ziptek, LLC. It received FDA 510(k) clearance on 2017-03-13 under approval 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. It is manufactured by Ziptek, LLC. The 510(k) number is K162429.

When was ZipE Knotless Tissue Repair and Attachment Devices approved by the FDA?

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

What company makes ZipE Knotless Tissue Repair and Attachment Devices?

ZipE Knotless Tissue Repair and Attachment Devices is manufactured by Ziptek, LLC.

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.

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Related PubMed Literature

PMID: 41516911 Substance-Based Medical Device in Wound Care: Bridging Regulatory Clarity and Therapeutic Innovation. Polymers (2025) PMID: 41273038 Optimization of the Nonclinical Biological Evaluation of Medical Devices Using Toxicologic Pathology Best Practices. Advanced healthcare materials (2026) PMID: 41269675 Pathology as a Core Discipline in the Biological Evaluation of Medical Devices. International journal of toxicology (2026) PMID: 40876809 Applications of Tissue-Inducing Biomaterials in Nonosseous Tissues: Evidence Map of Animal Studies. Tissue engineering. Part A (2026)

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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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