Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface Technology
K-Number: K223153 · 2022-12-16
ApplicantMedtronic Sofamor Danek USA, Inc.
Decision Date2022-12-16
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface Technology is a medical device manufactured by Medtronic Sofamor Danek USA, Inc.. It received FDA 510(k) clearance on 2022-12-16 under approval number K223153. 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 Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface Technology?
Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface Technology is a medical device that received FDA 510(k) clearance on 2022-12-16. It is manufactured by Medtronic Sofamor Danek USA, Inc.. The 510(k) number is K223153.
When was Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface Technology approved by the FDA?
Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface Technology received FDA 510(k) clearance on 2022-12-16, under approval number K223153.
What company makes Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface Technology?
Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface Technology is manufactured by Medtronic Sofamor Danek USA, Inc..
What is the FDA product code for Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface Technology?
The FDA product code for Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface Technology is MAX.
Related Clinical Trials
NCT07222787
Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes
RECRUITING
NCT07430293
Hybrid Closed-Loop Insulin Delivery After Pancreatectomy
RECRUITING
NCT06690658
Self-Practicing Upper Body Exercises With a Robotic Trainer System
RECRUITING
NCT06087445
A User-friendly, Non-invasive Neuro-orthosis That Restores Volitionally Controlled Grasp Functions for SCI Survivors With Tetraplegia
COMPLETED
NCT06335082
A Registry Based Collaborative to Measure Efficiency, Effectiveness, and Safety of Farapulse PFA Technology for AF
ENROLLING_BY_INVITATION
NCT07409545
Autonomic Nervous System Intrapartum Monitoring to Prevent Neonatal Adverse Outcomes
NOT_YET_RECRUITING
Related PubMed Literature
PMID: 41887630
Capacity building for ethical use of artificial intelligence in health: protocol for a scoping review of training initiatives and gaps in Africa.
BMJ open (2026)
PMID: 41054198
Relevant domains for health technology assessment of medical device reimbursement in Brazil's unified health system: a survey and Delphi panel study on stakeholder preferences.
International journal of technology assessment in health care (2025)
PMID: 40837401
Mining and evaluation of security alert signals of neuroprotective agents based on the Jinan adverse event reporting system database: a retrospective study.
Frontiers in pharmacology (2025)
PMID: 40407411
A data augmentation approach for an automatic speech recognition system using laser Doppler vibrometer technology.
JASA express letters (2025)
Other Devices by Medtronic Sofamor Danek USA, Inc.
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.