FDA 510(k)

28mm/38D MDM X3 Einbau für MDM Liner

K-Nummer: K233724 · 2024-03-11

AntragstellerHowmedica Osteonics Corp., Dba Stryker Orthopaedics

Entscheidungsdatum2024-03-11

ProduktcodeLZO

BeratungsausschussOR

EntscheidungSubstantially Equivalent

Produktübersicht

28mm/38D MDM X3 Insert for MDM Liner is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Osteonics Corp., Dba Stryker Orthopaedics. It received FDA 510(k) clearance on 2024-03-11 under 510(k) number K233724. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the 28mm/38D MDM X3 Insert for MDM Liner?

28mm/38D MDM X3 Insert for MDM Liner is a medical device that received FDA 510(k) clearance on 2024-03-11. The listed applicant is Howmedica Osteonics Corp., Dba Stryker Orthopaedics. The 510(k) number is K233724.

When did 28mm/38D MDM X3 Insert for MDM Liner receive FDA 510(k) clearance?

28mm/38D MDM X3 Insert for MDM Liner received FDA 510(k) clearance on 2024-03-11, under 510(k) number K233724.

Who is the listed applicant for 28mm/38D MDM X3 Insert for MDM Liner?

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

What is the FDA product code for 28mm/38D MDM X3 Insert for MDM Liner?

The FDA product code for 28mm/38D MDM X3 Insert for MDM Liner is LZO.

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Offizielle Quelle

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