FDA 510(k)

REFLECTION CROSS-LINKED UHMWPE ACETABULAR COMPONENTS

K-Number: K002747 · 2000-12-15

Decision Date2000-12-15

Product CodeLPH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

REFLECTION CROSS-LINKED 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 2000-12-15 under 510(k) number K002747. 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 CROSS-LINKED UHMWPE ACETABULAR COMPONENTS?

REFLECTION CROSS-LINKED UHMWPE ACETABULAR COMPONENTS is a medical device that received FDA 510(k) clearance on 2000-12-15. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K002747.

When did REFLECTION CROSS-LINKED UHMWPE ACETABULAR COMPONENTS receive FDA 510(k) clearance?

REFLECTION CROSS-LINKED UHMWPE ACETABULAR COMPONENTS received FDA 510(k) clearance on 2000-12-15, under 510(k) number K002747.

Who is the listed applicant for REFLECTION CROSS-LINKED 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 CROSS-LINKED UHMWPE ACETABULAR COMPONENTS?

The FDA product code for REFLECTION CROSS-LINKED 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.