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FDA 510(k)

Infinity-Lock Button System

K-Number: K180243 · 2018-04-03

ApplicantXiros, Ltd.
Decision Date2018-04-03
Product CodeHTN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Infinity-Lock Button System is the device name listed in this FDA 510(k) record. The listed applicant is Xiros, Ltd.. It received FDA 510(k) clearance on 2018-04-03 under 510(k) number K180243. The device is classified under product code HTN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Infinity-Lock Button System?

Infinity-Lock Button System is a medical device that received FDA 510(k) clearance on 2018-04-03. The listed applicant is Xiros, Ltd.. The 510(k) number is K180243.

When did Infinity-Lock Button System receive FDA 510(k) clearance?

Infinity-Lock Button System received FDA 510(k) clearance on 2018-04-03, under 510(k) number K180243.

Who is the listed applicant for Infinity-Lock Button System?

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 Infinity-Lock Button System?

The FDA product code for Infinity-Lock Button System is HTN.

Related Clinical Trials

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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.

K242237Jewel Soft Tissue Reinforcement Device (102-6005)K230671Pitch PaSoft Tissue Reinforcement DeviceK222978Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceK220091Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceK220906SECURE-LOCKK211563Pitch-Patchs

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Related Devices (Code: HTN)

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.

K253115LARS ACJMovmedix S.A.S.K252081SportLinc Syndesmosis DeviceLincotek MedicalK253727Syndesmosis TightRope PROArthrex, Inc.K251643Synchfix EVTWright Medical Technology, Inc. (Stryker Corporation)K251134RipCordTriMed, Inc.K243624Acu-Sinch Knotless MiniAcumed, LLC

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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