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FDA 510(k)

SPINAUT-P

K-Number: K150915 · 2016-03-18

ApplicantImedicom Co., Ltd.
Decision Date2016-03-18
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SPINAUT-P is a medical device manufactured by Imedicom Co., Ltd.. It received FDA 510(k) clearance on 2016-03-18 under approval number K150915. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPINAUT-P?

SPINAUT-P is a medical device that received FDA 510(k) clearance on 2016-03-18. It is manufactured by Imedicom Co., Ltd.. The 510(k) number is K150915.

When was SPINAUT-P approved by the FDA?

SPINAUT-P received FDA 510(k) clearance on 2016-03-18, under approval number K150915.

What company makes SPINAUT-P?

SPINAUT-P is manufactured by Imedicom Co., Ltd..

What is the FDA product code for SPINAUT-P?

The FDA product code for SPINAUT-P is GEI.

Other Devices by Imedicom Co., Ltd.

K153296MEDINAUT Kyphoplasty System K151268SPINAUT-V, SPINAUT-S, SPINAUT-I K150789SPINAUT-E, SPINAUT-I K173541EPINAUT K182287MEDINAUT Plus

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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.

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