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Sphynx

by Eden Spine, LLC

510(k) K160982

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK160982 Date22 Dec 2016ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
KWQ
Device Class
Class II
Regulation
21 CFR Part 888.3060
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The device is a plating system designed for spinal applications. It is intended to complement vertebral body replacement systems with rotatable endplates.

The Sphynx plating system is supplied by Eden Spine, LLC and has received FDA 510(k) clearance under K160982. It is classified under product code KWQ and reviewed by the Orthopedic advisory committee.

Other devices from Eden Spine, LLC

Questions

AI-generated answers, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Sphynx plating system intended for?

    The Sphynx plating system is designed for spinal applications and is intended to complement vertebral body replacement systems that feature rotatable endplates, providing structural support and stability in spinal reconstruction procedures.

  • Who manufactures the Sphynx plating system and what is its regulatory authorization?

    The Sphynx plating system is manufactured by Eden Spine, LLC and received FDA 510(k) clearance under submission number K160982, indicating it was found substantially equivalent to a legally marketed predicate device.

  • How is the Sphynx plating system classified and reviewed by the FDA?

    The device is classified under product code KWQ and was reviewed by the Orthopedic advisory committee as part of its traditional 510(k) submission process, which evaluates safety and effectiveness based on comparison to predicate devices.