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FDA 510(k)

Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal Augment

K-Number: K190991 · 2019-08-15

ApplicantHowmedica Osteonics Corp. (Aka Stryker Orthopaedics)
Decision Date2019-08-15
Product CodeMBH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal Augment is a medical device manufactured by Howmedica Osteonics Corp. (Aka Stryker Orthopaedics). It received FDA 510(k) clearance on 2019-08-15 under approval number K190991. The device is classified under product code MBH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal Augment?

Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal Augment is a medical device that received FDA 510(k) clearance on 2019-08-15. It is manufactured by Howmedica Osteonics Corp. (Aka Stryker Orthopaedics). The 510(k) number is K190991.

When was Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal Augment approved by the FDA?

Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal Augment received FDA 510(k) clearance on 2019-08-15, under approval number K190991.

What company makes Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal Augment?

Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal Augment is manufactured by Howmedica Osteonics Corp. (Aka Stryker Orthopaedics).

What is the FDA product code for Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal Augment?

The FDA product code for Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal Augment is MBH.

Related Clinical Trials

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Other Devices by Howmedica Osteonics Corp. (Aka Stryker Orthopaedics)

K193233Restoration® Modular Hip System

Related Devices (Code: MBH)

K162256Klassic Femur, Porous, Klassic Tibial Baseplate, PorousTotal Joint Orthopedics, Inc. K153657Vanguard XP Knee SystemBiomet, Inc. K153776Optetrak One Logic Femoral ComponentsExactech, Inc. K153586Arthrex iBalance TKA SystemArthrex, Inc. K172634Triathlon® X3® UHMWPE Tibial Inserts and Patellar ComponentsHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics K171365Arthrex Knee SystemsArthrex, 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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