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FDA 510(k)

S-Wire

K-Number: K152662 · 2016-03-09

ApplicantSpinal Resources, Inc.
Decision Date2016-03-09
Product CodeHTY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

S-Wire is the device name listed in this FDA 510(k) record. The listed applicant is Spinal Resources, Inc.. It received FDA 510(k) clearance on 2016-03-09 under 510(k) number K152662. The device is classified under product code HTY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the S-Wire?

S-Wire is a medical device that received FDA 510(k) clearance on 2016-03-09. The listed applicant is Spinal Resources, Inc.. The 510(k) number is K152662.

When did S-Wire receive FDA 510(k) clearance?

S-Wire received FDA 510(k) clearance on 2016-03-09, under 510(k) number K152662.

Who is the listed applicant for S-Wire?

The FDA 510(k) record lists Spinal Resources, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for S-Wire?

The FDA product code for S-Wire is HTY.

Other records listing Spinal Resources, Inc. as applicant

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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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