FDA 510(k)

S-Wire

K-Number: K152662 · 2016-03-09

Decision Date2016-03-09

Product CodeHTY

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

S-Wire is a medical device manufactured by Spinal Resources, Inc.. It received FDA 510(k) clearance on 2016-03-09 under approval 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. It is manufactured by Spinal Resources, Inc.. The 510(k) number is K152662.

When was S-Wire approved by the FDA?

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

What company makes S-Wire?

S-Wire is manufactured by Spinal Resources, Inc..

What is the FDA product code for S-Wire?

The FDA product code for S-Wire is HTY.

Other Devices by Spinal Resources, Inc.

K170045Swedge Pedicle Screw Fixation System K230482Swedge Pedicle Screw Fixation System K252461Swedge Pedicle Screw Fixation System Bezier Rod

Related Devices (Code: HTY)

K161489Syntorr K-wire and Pin SystemSyntorr, Inc. K160264Additive Orthopaedics Hammertoe Correction SystemAdditive Orthopaedics, LLC K160194StarFuse Interphalangeal PinPhalanx Innovations K153204In2Bones Kirschner wireIn2bones Sas K152627IFS Fixation Scaffold SystemMetric Medical Devices, Inc. K173013WishBone K-Wire SystemWishbone Medical, Inc.

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.