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FDA 510(k)

IvyAIR Meniscus System, Curved, IvyAIR Meniscus System, Straight, IvyAIR Meniscus System, Reverse Curved

K-Number: K153087 · 2016-07-14

ApplicantIvy Sports Medicine, LLC
Decision Date2016-07-14
Product CodeGAT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

IvyAIR Meniscus System, Curved, IvyAIR Meniscus System, Straight, IvyAIR Meniscus System, Reverse Curved is the device name listed in this FDA 510(k) record. The listed applicant is Ivy Sports Medicine, LLC. It received FDA 510(k) clearance on 2016-07-14 under 510(k) number K153087. 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 IvyAIR Meniscus System, Curved, IvyAIR Meniscus System, Straight, IvyAIR Meniscus System, Reverse Curved?

IvyAIR Meniscus System, Curved, IvyAIR Meniscus System, Straight, IvyAIR Meniscus System, Reverse Curved is a medical device that received FDA 510(k) clearance on 2016-07-14. The listed applicant is Ivy Sports Medicine, LLC. The 510(k) number is K153087.

When did IvyAIR Meniscus System, Curved, IvyAIR Meniscus System, Straight, IvyAIR Meniscus System, Reverse Curved receive FDA 510(k) clearance?

IvyAIR Meniscus System, Curved, IvyAIR Meniscus System, Straight, IvyAIR Meniscus System, Reverse Curved received FDA 510(k) clearance on 2016-07-14, under 510(k) number K153087.

Who is the listed applicant for IvyAIR Meniscus System, Curved, IvyAIR Meniscus System, Straight, IvyAIR Meniscus System, Reverse Curved?

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

What is the FDA product code for IvyAIR Meniscus System, Curved, IvyAIR Meniscus System, Straight, IvyAIR Meniscus System, Reverse Curved?

The FDA product code for IvyAIR Meniscus System, Curved, IvyAIR Meniscus System, Straight, IvyAIR Meniscus System, Reverse Curved is GAT.

Other records listing Ivy Sports Medicine, LLC 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.

K170364Collagen Meniscus Implant XL

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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