FDA 510(k)

SERIES II X3 LARGE DIAMETER ACCETABULAR INSERTS

K-Number: K103124 · 2010-11-19

Decision Date2010-11-19

Product CodeLPH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

SERIES II X3 LARGE DIAMETER ACCETABULAR INSERTS is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Corporation. It received FDA 510(k) clearance on 2010-11-19 under 510(k) number K103124. 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 SERIES II X3 LARGE DIAMETER ACCETABULAR INSERTS?

SERIES II X3 LARGE DIAMETER ACCETABULAR INSERTS is a medical device that received FDA 510(k) clearance on 2010-11-19. The listed applicant is Stryker Corporation. The 510(k) number is K103124.

When did SERIES II X3 LARGE DIAMETER ACCETABULAR INSERTS receive FDA 510(k) clearance?

SERIES II X3 LARGE DIAMETER ACCETABULAR INSERTS received FDA 510(k) clearance on 2010-11-19, under 510(k) number K103124.

Who is the listed applicant for SERIES II X3 LARGE DIAMETER ACCETABULAR INSERTS?

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

What is the FDA product code for SERIES II X3 LARGE DIAMETER ACCETABULAR INSERTS?

The FDA product code for SERIES II X3 LARGE DIAMETER ACCETABULAR INSERTS is LPH.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.