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FDA 510(k)

REFLECTION ACETABULAR REINFORCEMENT RINGS

K-Number: K962541 · 1996-09-17

ApplicantSmith & Nephew Richards, Inc.
Decision Date1996-09-17
Product CodeJDJ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

REFLECTION ACETABULAR REINFORCEMENT RINGS 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 1996-09-17 under 510(k) number K962541. The device is classified under product code JDJ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REFLECTION ACETABULAR REINFORCEMENT RINGS?

REFLECTION ACETABULAR REINFORCEMENT RINGS is a medical device that received FDA 510(k) clearance on 1996-09-17. The listed applicant is Smith & Nephew Richards, Inc.. The 510(k) number is K962541.

When did REFLECTION ACETABULAR REINFORCEMENT RINGS receive FDA 510(k) clearance?

REFLECTION ACETABULAR REINFORCEMENT RINGS received FDA 510(k) clearance on 1996-09-17, under 510(k) number K962541.

Who is the listed applicant for REFLECTION ACETABULAR REINFORCEMENT RINGS?

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 ACETABULAR REINFORCEMENT RINGS?

The FDA product code for REFLECTION ACETABULAR REINFORCEMENT RINGS is JDJ.

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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: JDJ)

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.

K972760LINK, ACETABULAR REVISION MESH CUPLink America, Inc.K970957OSTEONICS RESTORATION ACETABULAR RINGOsteonics Corp.K963940EXETER MESHHowmedica, Inc.K962007PROTRUSION CAGESDepuy, Inc.K925883OSTEONICS MICROSTRUCTURED ACETABULAR COMPONENTSOsteonics Corp.K890450INTERMEDICS APR(TM) II FEMORAL COMPONENTIntermedics Orthopedics

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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