FDA 510(k)

Tritanium® TL Curved Posterior Lumbar Cage

K-Number: K173476 · 2018-01-18

Decision Date2018-01-18

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Tritanium® TL Curved Posterior Lumbar Cage is a medical device manufactured by Stryker. It received FDA 510(k) clearance on 2018-01-18 under approval number K173476. 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 Tritanium® TL Curved Posterior Lumbar Cage?

Tritanium® TL Curved Posterior Lumbar Cage is a medical device that received FDA 510(k) clearance on 2018-01-18. It is manufactured by Stryker. The 510(k) number is K173476.

When was Tritanium® TL Curved Posterior Lumbar Cage approved by the FDA?

Tritanium® TL Curved Posterior Lumbar Cage received FDA 510(k) clearance on 2018-01-18, under approval number K173476.

What company makes Tritanium® TL Curved Posterior Lumbar Cage?

Tritanium® TL Curved Posterior Lumbar Cage is manufactured by Stryker.

What is the FDA product code for Tritanium® TL Curved Posterior Lumbar Cage?

The FDA product code for Tritanium® TL Curved Posterior Lumbar Cage is MAX.

Related Clinical Trials

NCT05362370 Stryker PEEK Customized Implant: A Prospective Post Market Follow Up to Evaluate Safety, Performance and Effectiveness ACTIVE_NOT_RECRUITING NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT04823858 3Spine Lumbar Fusion Real World Evidence Study ACTIVE_NOT_RECRUITING NCT06941558 The UK ADAPTIS Study ACTIVE_NOT_RECRUITING NCT07245758 Facial iD Customized Mandible Reconstruction Plates COMPLETED NCT07245719 Stryker Universal Midface and Upper-Face Fixation System: A Retrospective Post Market Follow Up COMPLETED

Other Devices by Stryker

K161821Stryker Universal Mesh K162310XBraid TT Suture Tape K162262Tritanium® PL Cage K160955Tritanium® PL Cage K153248PEEK Customized Cranial Implant K153508Stryker CMF MEDPOR Customized Implant

View all 64 devices →

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.