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FDA 510(k)

REFLECTION DUAL DIMENSION SHELL

K-Number: K960094 · 1996-03-27

ApplicantSmith & Nephew Richards, Inc.
Decision Date1996-03-27
Product CodeMBL
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

REFLECTION DUAL DIMENSION SHELL is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew Richards, Inc.. It received FDA 510(k) clearance on 1996-03-27 under 510(k) number K960094. 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 DUAL DIMENSION SHELL?

REFLECTION DUAL DIMENSION SHELL is a medical device that received FDA 510(k) clearance on 1996-03-27. The listed applicant is Smith & Nephew Richards, Inc.. The 510(k) number is K960094.

When did REFLECTION DUAL DIMENSION SHELL receive FDA 510(k) clearance?

REFLECTION DUAL DIMENSION SHELL received FDA 510(k) clearance on 1996-03-27, under 510(k) number K960094.

Who is the listed applicant for REFLECTION DUAL DIMENSION SHELL?

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

What is the FDA product code for REFLECTION DUAL DIMENSION SHELL?

The FDA product code for REFLECTION DUAL DIMENSION SHELL is MBL.

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Other records listing Smith & Nephew Richards, Inc. as applicant

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.

K965224EMPOWER ANTERIOR DIRECT SCREWSK963509GLOBAL TAPER TAPERED HIP SYSTEM, GT SPECTRONK960444FINN ROD TO ROD CONNECTORK964163TRIMAX NAIL SYSTEMK962557GENESIS II ZIRCONIUM FEMORAL COMPONENT/PROFIX ZIRCONIUM FEMORAL COMPONENTK963486REVISION HIP SYSTEM

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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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