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FDA 510(k)

Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody System

K-Number: K231438 · 2023-07-13

ApplicantAlphatec Spine, Inc.
Decision Date2023-07-13
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody System is a medical device manufactured by Alphatec Spine, Inc.. It received FDA 510(k) clearance on 2023-07-13 under approval number K231438. 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 PSX Interbody System, Calibrate NanoTec PSX Interbody System?

Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody System is a medical device that received FDA 510(k) clearance on 2023-07-13. It is manufactured by Alphatec Spine, Inc.. The 510(k) number is K231438.

When was Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody System approved by the FDA?

Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody System received FDA 510(k) clearance on 2023-07-13, under approval number K231438.

What company makes Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody System?

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

What is the FDA product code for Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody System?

The FDA product code for Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody System is MAX.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07611721 Evaluate the Performance of the Dexcom G7 Continuous Glucose Monitoring (CGM) System in Critically Ill Patients Undergoing Major Abdominal Surgery and Solid Organ Transplantation Which Require Blood Glucose Monitoring for Intensive Insulin Therapy. RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION

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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.

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