FDA 510(k)

REFLECTION CROSSLINKED UHMWPE ACETABULAR COMPONENTS

K-Number: K991026 · 1999-10-22

Decision Date1999-10-22

Product CodeLPH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

REFLECTION CROSSLINKED UHMWPE ACETABULAR COMPONENTS is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew, Inc.. It received FDA 510(k) clearance on 1999-10-22 under 510(k) number K991026. 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 REFLECTION CROSSLINKED UHMWPE ACETABULAR COMPONENTS?

REFLECTION CROSSLINKED UHMWPE ACETABULAR COMPONENTS is a medical device that received FDA 510(k) clearance on 1999-10-22. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K991026.

When did REFLECTION CROSSLINKED UHMWPE ACETABULAR COMPONENTS receive FDA 510(k) clearance?

REFLECTION CROSSLINKED UHMWPE ACETABULAR COMPONENTS received FDA 510(k) clearance on 1999-10-22, under 510(k) number K991026.

Who is the listed applicant for REFLECTION CROSSLINKED UHMWPE ACETABULAR COMPONENTS?

The FDA 510(k) record lists Smith & Nephew, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REFLECTION CROSSLINKED UHMWPE ACETABULAR COMPONENTS?

The FDA product code for REFLECTION CROSSLINKED UHMWPE ACETABULAR COMPONENTS 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.