FDA 510(k)

R3 MULTI-HOLE SHELLS AND 36MM XLPE ACETABULAR LINERS

K-Number: K092386 · 2009-11-03

Decision Date2009-11-03

Product CodeMBL

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

R3 MULTI-HOLE SHELLS AND 36MM XLPE ACETABULAR LINERS 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 2009-11-03 under 510(k) number K092386. The device is classified under product code MBL. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the R3 MULTI-HOLE SHELLS AND 36MM XLPE ACETABULAR LINERS?

R3 MULTI-HOLE SHELLS AND 36MM XLPE ACETABULAR LINERS is a medical device that received FDA 510(k) clearance on 2009-11-03. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K092386.

When did R3 MULTI-HOLE SHELLS AND 36MM XLPE ACETABULAR LINERS receive FDA 510(k) clearance?

R3 MULTI-HOLE SHELLS AND 36MM XLPE ACETABULAR LINERS received FDA 510(k) clearance on 2009-11-03, under 510(k) number K092386.

Who is the listed applicant for R3 MULTI-HOLE SHELLS AND 36MM XLPE ACETABULAR LINERS?

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 R3 MULTI-HOLE SHELLS AND 36MM XLPE ACETABULAR LINERS?

The FDA product code for R3 MULTI-HOLE SHELLS AND 36MM XLPE ACETABULAR LINERS is MBL.

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Related Devices (Code: MBL)

K201157Prime BIOFOAM® Multi-Hole ShellsMicroport Orthopedics, Inc.K201701R3 HA Coated Acetabular ShellsSmith & Nephew, Inc.K182535R3 Anteverted LinersSmith & Nephew, Inc.K161233OXINIUM DH Fermoral HeadsSmith & Nephew, Inc.K122382DYNASTY BIOFOAM SHELLWrightmedicaltechnologyinc K113848R3 XLPE LINERSSmith & Nephew, Inc.

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.