FDA 510(k)

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

Numéro K : K222988 · 2023-09-01

DemandeurHt Medical D.B.A. Xenix Medical

Date de décision2023-09-01

Code produitODP

Comité consultatifOR

DécisionSubstantially Equivalent

Résumé du dispositif

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.

Questions fréquentes

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.

Essais cliniques associés

Les enregistrements connexes sont mis en correspondance automatiquement à l'aide des noms, codes produits ou autres métadonnées. Une mise en correspondance n'établit pas de relation clinique, scientifique, corporative ou réglementaire vérifiée ; veuillez consulter les sources officielles liées.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Autres dossiers indiquant Ht Medical D.B.A. Xenix Medical en tant que demandeur

K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation Instruments K231829Xenix Medical Sacroiliac Fixation System

Dispositifs connexes (Code : ODP)

K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.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 Spine K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC K260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.

Source officielle

Voir dans la base de données FDA →

Données issues de l'API ouverte de la FDA. Pour les informations les plus récentes et faisant autorité, veuillez toujours vous référer au registre officiel.