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neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D Cervical

by Ht Medical D.B.A. Xenix Medical

510(k) K222988

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 NumberK222988 Date1 Sep 2023ClearedStatusActive

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  • Withdrawn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
ODP
Device Class
Class II
Regulation
21 CFR Part 888.3080
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 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 neoWave LS Porous Titanium Cage is an intervertebral body fusion device indicated for skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. The device combines a lattice structure with a NANOACTIV surface and is available in a range of implant sizes to accommodate various anatomical requirements.

The neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D Cervical are supplied as sterile, single-use devices. They are classified as an Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls, and received FDA 510(k) clearance with K222988. The devices are manufactured by Ht Medical D.B.A. Xenix Medical.

Other devices from Ht Medical, LLC Dba Xenix Medical

Questions

AI-generated answers, 22 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 neoWave LS Lumbar Straight device used for?

    The neoWave LS Lumbar Straight is an intervertebral body fusion device indicated for skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1.

  • How are the neoWave devices supplied and are they reusable?

    The neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D Cervical are supplied as sterile, single-use devices. They are not intended for reuse and should be discarded after a single surgical procedure.

  • What regulatory status do these devices have?

    The devices are classified as an Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls, and received FDA 510(k) clearance with K222988.

  • What surface technology is incorporated in the neoWave LS device?

    The neoWave LS device combines a lattice structure with a NANOACTIV surface, which is designed to promote bone integration and fusion in the lumbar spine.