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FDA 510(k)

Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial Inserts

K-Number: K180612 · 2018-06-07

ApplicantHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics
Decision Date2018-06-07
Product CodeHSX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial Inserts is a medical device manufactured by Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics. It received FDA 510(k) clearance on 2018-06-07 under approval number K180612. The device is classified under product code HSX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial Inserts?

Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial Inserts is a medical device that received FDA 510(k) clearance on 2018-06-07. It is manufactured by Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics. The 510(k) number is K180612.

When was Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial Inserts approved by the FDA?

Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial Inserts received FDA 510(k) clearance on 2018-06-07, under approval number K180612.

What company makes Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial Inserts?

Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial Inserts is manufactured by Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics.

What is the FDA product code for Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial Inserts?

The FDA product code for Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial Inserts is HSX.

Related Clinical Trials

NCT04358601 All-poly Versus Metal-backed ACTIVE_NOT_RECRUITING

Other Devices by Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics

K161569Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex Screws K172634Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components K171768Trident® II Acetabular System K191358Trident II Acetabular System K182468Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip System K203099Triathlon PKR System

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Related Devices (Code: HSX)

K161060Arthrex iBalance UKA System Vitamin E Tibial BearingArthrex, Inc. K161592Persona Partial Knee SystemBiomet, Inc. K160738ZUK Select Knee SystemSmith & Nephew, Inc. K172650Materialise PKA Guide SystemMaterialise NV K170344Tahoe Uni Knee SystemConsensus Orthopedics, Inc. K161741GMK UNIMedacta International S.A.

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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