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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 the device name listed in this FDA 510(k) record. The listed applicant is Imedicom Co., Ltd.. It received FDA 510(k) clearance on 2016-03-18 under 510(k) 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. The listed applicant is Imedicom Co., Ltd.. The 510(k) number is K150915.

When did SPINAUT-P receive FDA 510(k) clearance?

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

Who is the listed applicant for SPINAUT-P?

The FDA 510(k) record lists Imedicom Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPINAUT-P?

The FDA product code for SPINAUT-P is GEI.

Other records listing Imedicom Co., 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.

K182287MEDINAUT PlusK173541EPINAUTK153296MEDINAUT Kyphoplasty SystemK151268SPINAUT-V, SPINAUT-S, SPINAUT-IK150789SPINAUT-E, SPINAUT-I

Related Devices (Code: GEI)

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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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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