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FDA 510(k)

LEGEND ALL-POLY CUP

K-Number: K051407 · 2005-09-08

ApplicantOrtho Development Corp.
Decision Date2005-09-08
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LEGEND ALL-POLY CUP 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 2005-09-08 under 510(k) number K051407. The device is classified under product code JDI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LEGEND ALL-POLY CUP?

LEGEND ALL-POLY CUP is a medical device that received FDA 510(k) clearance on 2005-09-08. The listed applicant is Ortho Development Corp.. The 510(k) number is K051407.

When did LEGEND ALL-POLY CUP receive FDA 510(k) clearance?

LEGEND ALL-POLY CUP received FDA 510(k) clearance on 2005-09-08, under 510(k) number K051407.

Who is the listed applicant for LEGEND ALL-POLY CUP?

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 ALL-POLY CUP?

The FDA product code for LEGEND ALL-POLY CUP is JDI.

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Related Devices (Code: JDI)

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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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