FDA 510(k)

TruLift® Lateral Expandable Spacer & Lateral Buttress Plate System

Numéro K : K251502 · 2025-07-07

Date de décision2025-07-07

Code produitMAX

Comité consultatifOR

DécisionSubstantially Equivalent

Résumé du dispositif

TruLift® Lateral Expandable Spacer & Lateral Buttress Plate System is the device name listed in this FDA 510(k) record. The listed applicant is Life Spine, Inc.. It received FDA 510(k) clearance on 2025-07-07 under 510(k) number K251502. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the TruLift® Lateral Expandable Spacer & Lateral Buttress Plate System?

TruLift® Lateral Expandable Spacer & Lateral Buttress Plate System is a medical device that received FDA 510(k) clearance on 2025-07-07. The listed applicant is Life Spine, Inc.. The 510(k) number is K251502.

When did TruLift® Lateral Expandable Spacer & Lateral Buttress Plate System receive FDA 510(k) clearance?

TruLift® Lateral Expandable Spacer & Lateral Buttress Plate System received FDA 510(k) clearance on 2025-07-07, under 510(k) number K251502.

Who is the listed applicant for TruLift® Lateral Expandable Spacer & Lateral Buttress Plate System?

The FDA 510(k) record lists Life Spine, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TruLift® Lateral Expandable Spacer & Lateral Buttress Plate System?

The FDA product code for TruLift® Lateral Expandable Spacer & Lateral Buttress Plate System is MAX.

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 Life Spine, Inc. en tant que demandeur

K261430TruLift Expandable System K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments K260837VersaLift Expandable System K254274Système d'implantation ARx® SAI K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer System K250373ProLift Expandable Spacer System

Voir tous les 66 dispositifs →

Dispositifs connexes (Code : MAX)

K261049SCALA® TLSpineart SA K261430TruLift Expandable SystemLife Spine, Inc.K253011Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody SySeaSpine Orthopedics Corporation K253151Système de Cage de Fusion Intervertébral FuleBeijing Fule Science & Technology Development 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.