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FDA 510(k)

Legend® Acetabular Shell

K-Number: K242833 · 2024-10-11

ApplicantOrtho Development Corp.
Decision Date2024-10-11
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Legend® Acetabular Shell is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Development Corp.. It received FDA 510(k) clearance on 2024-10-11 under 510(k) number K242833. 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 Legend® Acetabular Shell?

Legend® Acetabular Shell is a medical device that received FDA 510(k) clearance on 2024-10-11. The listed applicant is Ortho Development Corp.. The 510(k) number is K242833.

When did Legend® Acetabular Shell receive FDA 510(k) clearance?

Legend® Acetabular Shell received FDA 510(k) clearance on 2024-10-11, under 510(k) number K242833.

Who is the listed applicant for Legend® Acetabular Shell?

The FDA 510(k) record lists Ortho Development Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Legend® Acetabular Shell?

The FDA product code for Legend® Acetabular Shell is LPH.

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Related Devices (Code: LPH)

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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