FDA 510(k)

Acetabular Dome Hole Plug

K-Number: K220376 · 2022-03-09

ApplicantHowmedica Osteonics Corp., Dba Stryker Orthopaedics

Decision Date2022-03-09

Product CodeLPH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Acetabular Dome Hole Plug 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 2022-03-09 under 510(k) number K220376. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Acetabular Dome Hole Plug?

Acetabular Dome Hole Plug is a medical device that received FDA 510(k) clearance on 2022-03-09. The listed applicant is Howmedica Osteonics Corp., Dba Stryker Orthopaedics. The 510(k) number is K220376.

When did Acetabular Dome Hole Plug receive FDA 510(k) clearance?

Acetabular Dome Hole Plug received FDA 510(k) clearance on 2022-03-09, under 510(k) number K220376.

Who is the listed applicant for Acetabular Dome Hole Plug?

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 Acetabular Dome Hole Plug?

The FDA product code for Acetabular Dome Hole Plug is LPH.

Other records listing Howmedica Osteonics Corp., Dba Stryker Orthopaedics as applicant

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Related Devices (Code: LPH)

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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.