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FDA 510(k)

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

K-Number: K222988 · 2023-09-01

ApplicantHt Medical D.B.A. Xenix Medical
Decision Date2023-09-01
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D Cervical is the device name listed in this FDA 510(k) record. The listed applicant is Ht Medical D.B.A. Xenix Medical. It received FDA 510(k) clearance on 2023-09-01 under 510(k) number K222988. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D Cervical?

neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D Cervical is a medical device that received FDA 510(k) clearance on 2023-09-01. The listed applicant is Ht Medical D.B.A. Xenix Medical. The 510(k) number is K222988.

When did neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D Cervical receive FDA 510(k) clearance?

neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D Cervical received FDA 510(k) clearance on 2023-09-01, under 510(k) number K222988.

Who is the listed applicant for neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D Cervical?

The FDA 510(k) record lists Ht Medical D.B.A. Xenix Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D Cervical?

The FDA product code for neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D Cervical is ODP.

Other records listing Ht Medical D.B.A. Xenix Medical as applicant

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.

K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsK231829Xenix Medical Sacroiliac Fixation System

Related Devices (Code: ODP)

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.

K2530413d Cage CervicalFims Co., Ltd.K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero® -C Cervical Cage System; AVS® Anchor-C Cervical Cage System; AVS® TL PEEK Spacer; AVS® PL PEEK Spacers; AVS® Navigator PEEK Spacer; AVS® AS PEEK Spacer; Monterey™ AL Interbody System; Aleutian IBF System; Cascadia Interbody System; Chesapeake Stabilization System; Sahara Stabilization System; SANTORINI™ Corpectomy Cage System; MOJAVE Interbody System; VLIFT VERTEBRAL BODY REPLACEMStryker SpineK254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLCK260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.K260850OSTEOMNI SPINAL CAGES SYSTEMOsteomni, Inc.K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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