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FDA 510(k)

R3 XLPE ANTEVERTED LINERS

K-Number: K102370 · 2011-01-19

ApplicantSmith & Nephew, Inc.
Decision Date2011-01-19
Product CodeMBL
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

R3 XLPE ANTEVERTED 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 2011-01-19 under 510(k) number K102370. 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 XLPE ANTEVERTED LINERS?

R3 XLPE ANTEVERTED LINERS is a medical device that received FDA 510(k) clearance on 2011-01-19. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K102370.

When did R3 XLPE ANTEVERTED LINERS receive FDA 510(k) clearance?

R3 XLPE ANTEVERTED LINERS received FDA 510(k) clearance on 2011-01-19, under 510(k) number K102370.

Who is the listed applicant for R3 XLPE ANTEVERTED 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 XLPE ANTEVERTED LINERS?

The FDA product code for R3 XLPE ANTEVERTED LINERS is MBL.

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Other records listing Smith & Nephew, Inc. as applicant

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Related Devices (Code: MBL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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 SHELLWrightmedicaltechnologyincK113848R3 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.

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