FDA 510(k)

OPERA CUPFLANGED ACETABULAR COMPONENTS

K-Number: K991538 · 1999-06-03

ApplicantSmith & Nephew, Inc., Orthopaedic Div.

Decision Date1999-06-03

Product CodeJDI

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

OPERA CUPFLANGED ACETABULAR COMPONENTS is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew, Inc., Orthopaedic Div.. It received FDA 510(k) clearance on 1999-06-03 under 510(k) number K991538. 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 OPERA CUPFLANGED ACETABULAR COMPONENTS?

OPERA CUPFLANGED ACETABULAR COMPONENTS is a medical device that received FDA 510(k) clearance on 1999-06-03. The listed applicant is Smith & Nephew, Inc., Orthopaedic Div.. The 510(k) number is K991538.

When did OPERA CUPFLANGED ACETABULAR COMPONENTS receive FDA 510(k) clearance?

OPERA CUPFLANGED ACETABULAR COMPONENTS received FDA 510(k) clearance on 1999-06-03, under 510(k) number K991538.

Who is the listed applicant for OPERA CUPFLANGED ACETABULAR COMPONENTS?

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

What is the FDA product code for OPERA CUPFLANGED ACETABULAR COMPONENTS?

The FDA product code for OPERA CUPFLANGED ACETABULAR COMPONENTS is 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.