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FDA 510(k)

Infinity-Lock 3, Infinity-Lock 5

K-Number: K171680 · 2017-06-30

ApplicantXiros, Ltd.
Decision Date2017-06-30
Product CodeGAT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Infinity-Lock 3, Infinity-Lock 5 is the device name listed in this FDA 510(k) record. The listed applicant is Xiros, Ltd.. It received FDA 510(k) clearance on 2017-06-30 under 510(k) number K171680. The device is classified under product code GAT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Infinity-Lock 3, Infinity-Lock 5?

Infinity-Lock 3, Infinity-Lock 5 is a medical device that received FDA 510(k) clearance on 2017-06-30. The listed applicant is Xiros, Ltd.. The 510(k) number is K171680.

When did Infinity-Lock 3, Infinity-Lock 5 receive FDA 510(k) clearance?

Infinity-Lock 3, Infinity-Lock 5 received FDA 510(k) clearance on 2017-06-30, under 510(k) number K171680.

Who is the listed applicant for Infinity-Lock 3, Infinity-Lock 5?

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 3, Infinity-Lock 5?

The FDA product code for Infinity-Lock 3, Infinity-Lock 5 is GAT.

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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.

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Related Devices (Code: GAT)

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.

K261021EasyWhip FamilyWinter Innovations, Inc.K260775Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™Teleflex Medical, LLCK254275HyperSuture All Green Extension LineThreadstone, LLCK254188Meniscus VersaflexGM Dos Reis Industria e Comercio Ltda.K253145Pre-Sutured TendonRti Surgical, Inc.K253024ProZip Knotless ImplantRiverpoint Medical

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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