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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 a medical device manufactured by Ivy Sports Medicine, LLC. It received FDA 510(k) clearance on 2016-07-14 under approval 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. It is manufactured by Ivy Sports Medicine, LLC. The 510(k) number is K153087.

When was IvyAIR Meniscus System, Curved, IvyAIR Meniscus System, Straight, IvyAIR Meniscus System, Reverse Curved approved by the FDA?

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

What company makes 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 manufactured by Ivy Sports Medicine, LLC.

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.

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Other Devices by Ivy Sports Medicine, LLC

K170364Collagen Meniscus Implant XL

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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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