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Spine Wave Navigated Instruments

by Spine Wave, Inc. 2 variants

510(k) K181596

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK181596 Date24 Oct 2018ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 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  • Withdrawn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
OLO
Device class
Class II
Regulation
21 CFR Part 882.4560
Advisory committee
Neurology
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 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 Spine Wave Navigated Instruments are specialized surgical tools designed for use in spinal procedures. These instruments are engineered to facilitate navigation during surgery, assisting the surgeon in precise placement and alignment.

This device is supplied as a traditional 510(k) cleared medical instrument set. It is intended for use in a clinical setting by qualified medical professionals. The product is identified by K-number K181596 and is regulated under the neurology advisory committee.

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Questions

AI-generated answers, 23 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 are Spine Wave Navigated Instruments used for?

    These instruments are specialized surgical tools engineered to facilitate navigation during spinal procedures. They are designed to assist the surgeon in achieving precise placement and alignment of components within the surgical site.

  • Who is authorized to use these surgical instruments?

    The Spine Wave Navigated Instruments are intended for use exclusively in a clinical setting by qualified medical professionals who are trained in spinal surgical techniques.

  • What is the regulatory status of this instrument set?

    The Spine Wave Navigated Instruments are supplied as a traditional 510(k) cleared medical instrument set, identified by K-number K181596. The device was reviewed under the neurology advisory committee.