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FDA 510(k)

REFLECTION 3 ACETABULAR SYSTEM

K-Number: K061253 · 2006-05-31

ApplicantSmith & Nephew, Inc.
Decision Date2006-05-31
Product CodeMBL
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

REFLECTION 3 ACETABULAR SYSTEM 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 2006-05-31 under 510(k) number K061253. 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 REFLECTION 3 ACETABULAR SYSTEM?

REFLECTION 3 ACETABULAR SYSTEM is a medical device that received FDA 510(k) clearance on 2006-05-31. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K061253.

When did REFLECTION 3 ACETABULAR SYSTEM receive FDA 510(k) clearance?

REFLECTION 3 ACETABULAR SYSTEM received FDA 510(k) clearance on 2006-05-31, under 510(k) number K061253.

Who is the listed applicant for REFLECTION 3 ACETABULAR SYSTEM?

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 3 ACETABULAR SYSTEM?

The FDA product code for REFLECTION 3 ACETABULAR SYSTEM 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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