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FDA 510(k)

Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device

K-Number: K222978 · 2022-12-27

ApplicantXiros, Ltd.
Decision Date2022-12-27
Product CodeQUW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device is the device name listed in this FDA 510(k) record. The listed applicant is Xiros, Ltd.. It received FDA 510(k) clearance on 2022-12-27 under 510(k) number K222978. The device is classified under product code QUW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device?

Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device is a medical device that received FDA 510(k) clearance on 2022-12-27. The listed applicant is Xiros, Ltd.. The 510(k) number is K222978.

When did Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device receive FDA 510(k) clearance?

Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device received FDA 510(k) clearance on 2022-12-27, under 510(k) number K222978.

Who is the listed applicant for Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device?

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

What is the FDA product code for Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device?

The FDA product code for Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device is QUW.

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.

Other records listing Xiros, Ltd. 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.

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Related Devices (Code: QUW)

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.

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.