FDA 510(k)

Sphynx™

K-Number: K160982 · 2016-12-22

Decision Date2016-12-22

Product CodeKWQ

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Sphynx™ is the device name listed in this FDA 510(k) record. The listed applicant is Eden Spine, LLC. It received FDA 510(k) clearance on 2016-12-22 under 510(k) number K160982. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sphynx™?

Sphynx™ is a medical device that received FDA 510(k) clearance on 2016-12-22. The listed applicant is Eden Spine, LLC. The 510(k) number is K160982.

When did Sphynx™ receive FDA 510(k) clearance?

Sphynx™ received FDA 510(k) clearance on 2016-12-22, under 510(k) number K160982.

Who is the listed applicant for Sphynx™?

The FDA 510(k) record lists Eden Spine, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sphynx™?

The FDA product code for Sphynx™ is KWQ.

Related Devices (Code: KWQ)

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.

K261309Palisades™ Buttress Plate SystemBethesda Medical Devices, LLC K252776ARIES Anterior Cervical Plate SystemsZheJiang Decans Medical Devices Co., Ltd.K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.K260570corra™ cervical plating systemCarlsmed, Inc.K260697VyPlate™ Anterior Cervical Plate SystemVy Spine, LLC K260015ANTERIS Thoracolumbar Plate SystemSpineCraft

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.