FDA 510(k)

Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody System

Numéro K : K242147 · 2024-09-20

Date de décision2024-09-20

Code produitMAX

Comité consultatifOR

DécisionSubstantially Equivalent

Résumé du dispositif

Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody System is the device name listed in this FDA 510(k) record. The listed applicant is Alphatec Spine, Inc.. It received FDA 510(k) clearance on 2024-09-20 under 510(k) number K242147. 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 Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody System?

Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody System is a medical device that received FDA 510(k) clearance on 2024-09-20. The listed applicant is Alphatec Spine, Inc.. The 510(k) number is K242147.

When did Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody System receive FDA 510(k) clearance?

Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody System received FDA 510(k) clearance on 2024-09-20, under 510(k) number K242147.

Who is the listed applicant for Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody System?

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

What is the FDA product code for Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody System?

The FDA product code for Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody System is MAX.

Essais cliniques associés

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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

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