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STYLO Interbody Fusion Device

by Legend Spine Technologies

510(k) K180071

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 NumberK180071 Date3 May 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  • Withdrawn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
MAX
Device Class
Class II
Regulation
21 CFR Part 888.3080
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 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 STYLO Interbody Fusion Device is an orthopedic implant designed for spinal fusion procedures. It is intended to facilitate bone growth between adjacent vertebrae to stabilize the spine.

The device is supplied non-sterile and is intended for single-use. It is manufactured by Legend Spine Technologies and received FDA 510(k) clearance (K180071) on May 3, 2018, under product code MAX. It is not MRI safety information provided in the data.

Other devices from Legend Spine Technologies

Questions

AI-generated answers, 21 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 STYLO Interbody Fusion Device used for?

    The STYLO Interbody Fusion Device is an orthopedic implant designed to facilitate bone growth between adjacent vertebrae during spinal fusion procedures, helping to stabilize the spine.

  • Is the STYLO Interbody Fusion Device sterile when supplied?

    The device is supplied non-sterile and must be sterilized by the user before implantation, as it is intended for single-use only.

  • Can the STYLO Interbody Fusion Device be reused after implantation?

    No, the STYLO Interbody Fusion Device is intended for single-use only and should not be reused, as reusing it may compromise patient safety and device integrity.

  • Who manufactures the STYLO Interbody Fusion Device and what is its FDA clearance number?

    The STYLO Interbody Fusion Device is manufactured by Legend Spine Technologies and received FDA 510(k) clearance under number K180071 on May 3, 2018.

  • What product code was assigned to the STYLO Interbody Fusion Device in its FDA 510(k) submission?

    The STYLO Interbody Fusion Device was assigned product code MAX in its FDA 510(k) submission, which falls under the Orthopedic advisory committee classification.