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FDA 510(k)

Tritanium® PL Cage

K-Number: K162262 · 2016-11-09

ApplicantStryker
Decision Date2016-11-09
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Tritanium® PL Cage is a medical device manufactured by Stryker. It received FDA 510(k) clearance on 2016-11-09 under approval number K162262. 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® PL Cage?

Tritanium® PL Cage is a medical device that received FDA 510(k) clearance on 2016-11-09. It is manufactured by Stryker. The 510(k) number is K162262.

When was Tritanium® PL Cage approved by the FDA?

Tritanium® PL Cage received FDA 510(k) clearance on 2016-11-09, under approval number K162262.

What company makes Tritanium® PL Cage?

Tritanium® PL Cage is manufactured by Stryker.

What is the FDA product code for Tritanium® PL Cage?

The FDA product code for Tritanium® PL Cage is MAX.

Related Clinical Trials

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Other Devices by Stryker

K161821Stryker Universal Mesh K162310XBraid TT Suture Tape K160955Tritanium® PL Cage K153248PEEK Customized Cranial Implant K153508Stryker CMF MEDPOR Customized Implant K172921Stryker Self-Punching ICONIX

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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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