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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 the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics. It received FDA 510(k) clearance on 2018-06-07 under 510(k) 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. The listed applicant is Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics. The 510(k) number is K180612.

When did Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial Inserts receive FDA 510(k) clearance?

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

Who is the listed applicant for Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial Inserts?

The FDA 510(k) record lists Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics as applicant

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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.

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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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