FDA 510(k)

Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody System

K-Number: K242147 · 2024-09-20

Decision Date2024-09-20

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody System is a medical device manufactured by Alphatec Spine, Inc.. It received FDA 510(k) clearance on 2024-09-20 under approval number K242147. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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. It is manufactured by Alphatec Spine, Inc.. The 510(k) number is K242147.

When was Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody System approved by the FDA?

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

What company makes Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody System?

Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody System is manufactured by Alphatec Spine, Inc..

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.

Related Clinical Trials

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Related Devices (Code: MAX)

K163180Hubble IIOrbbo Surgical, LLC K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK Lateral Interbody Fusion SystemOrthofix, Inc. K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL K162103Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon), Choice Spine Interbody Fusion System (Harrier), Choice Spine Vertebral Body Replacement System (Hawkeye)Choicespine, LP K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc. K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, 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.