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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 the device name listed in this FDA 510(k) record. The listed applicant is Stryker. It received FDA 510(k) clearance on 2016-11-09 under 510(k) 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. The listed applicant is Stryker. The 510(k) number is K162262.

When did Tritanium® PL Cage receive FDA 510(k) clearance?

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

Who is the listed applicant for Tritanium® PL Cage?

The FDA 510(k) record lists Stryker as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT04214535Anterior Cervical Disectomy And Fusion Using The Tritanium® C Anterior Cervical Cage For One Or Two-LevelsACTIVE_NOT_RECRUITING

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Related Devices (Code: MAX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261430TruLift Expandable SystemLife Spine, Inc.K253011Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody SySeaSpine Orthopedics CorporationK253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, 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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