FDA 510(k)

SPINAUT-V, SPINAUT-S, SPINAUT-I

K-Number: K151268 · 2016-03-16

Decision Date2016-03-16

Product CodeHRX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

SPINAUT-V, SPINAUT-S, SPINAUT-I is a medical device manufactured by Imedicom Co., Ltd.. It received FDA 510(k) clearance on 2016-03-16 under approval number K151268. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPINAUT-V, SPINAUT-S, SPINAUT-I?

SPINAUT-V, SPINAUT-S, SPINAUT-I is a medical device that received FDA 510(k) clearance on 2016-03-16. It is manufactured by Imedicom Co., Ltd.. The 510(k) number is K151268.

When was SPINAUT-V, SPINAUT-S, SPINAUT-I approved by the FDA?

SPINAUT-V, SPINAUT-S, SPINAUT-I received FDA 510(k) clearance on 2016-03-16, under approval number K151268.

What company makes SPINAUT-V, SPINAUT-S, SPINAUT-I?

SPINAUT-V, SPINAUT-S, SPINAUT-I is manufactured by Imedicom Co., Ltd..

What is the FDA product code for SPINAUT-V, SPINAUT-S, SPINAUT-I?

The FDA product code for SPINAUT-V, SPINAUT-S, SPINAUT-I is HRX.

Other Devices by Imedicom Co., Ltd.

K153296MEDINAUT Kyphoplasty System K150915SPINAUT-P 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.