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FDA 510(k)

Tritanium PL Cage

K-Number: K181014 · 2018-07-18

ApplicantStryker Spine
Decision Date2018-07-18
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Tritanium PL Cage is a medical device manufactured by Stryker Spine. It received FDA 510(k) clearance on 2018-07-18 under approval number K181014. 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 2018-07-18. It is manufactured by Stryker Spine. The 510(k) number is K181014.

When was Tritanium PL Cage approved by the FDA?

Tritanium PL Cage received FDA 510(k) clearance on 2018-07-18, under approval number K181014.

What company makes Tritanium PL Cage?

Tritanium PL Cage is manufactured by Stryker Spine.

What is the FDA product code for Tritanium PL Cage?

The FDA product code for Tritanium PL Cage is MAX.

Other Devices by Stryker Spine

K161407Ascential IBD PEEKc Spacer K171496Tritanium C Anterior Cervical Cage K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved Posterior Lumbar Cage K183071VLIFT-s Vertebral Body Replacement System K200666Stryker Xia 3 Power Adaptor K203205Navigated Spine Instruments

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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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