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FDA 510(k)

RMHS MONOLITHIC FEMORAL COMPONENT

K-Number: K931642 · 1994-04-29

ApplicantSmith & Nephew Richards, Inc.
Decision Date1994-04-29
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

RMHS MONOLITHIC FEMORAL COMPONENT 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 1994-04-29 under 510(k) number K931642. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RMHS MONOLITHIC FEMORAL COMPONENT?

RMHS MONOLITHIC FEMORAL COMPONENT is a medical device that received FDA 510(k) clearance on 1994-04-29. The listed applicant is Smith & Nephew Richards, Inc.. The 510(k) number is K931642.

When did RMHS MONOLITHIC FEMORAL COMPONENT receive FDA 510(k) clearance?

RMHS MONOLITHIC FEMORAL COMPONENT received FDA 510(k) clearance on 1994-04-29, under 510(k) number K931642.

Who is the listed applicant for RMHS MONOLITHIC FEMORAL COMPONENT?

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 RMHS MONOLITHIC FEMORAL COMPONENT?

The FDA product code for RMHS MONOLITHIC FEMORAL COMPONENT is LPH.

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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: LPH)

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.

K261453G7® Acetabular SystemZimmer BiometK253630Mpact 3D Metal FoamMedacta International S.A.K254043TRIVANCE™ Hip StemGlobus Medical, Inc.K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert; Trident® Crossfire® 0° Polyethylene Insert; Trident ® Crossfire ® 10° Polyethylene Insert;System 12 Crossfire® 10° Insert; Trident® 0° Constrained Acetabular Insert; Trident® Constrained Acetabular Liner;Trident® All Poly Constrained Acetabular Insert; Crossfire® Eccentric Insert 10°; Artisan® Bone Plug;UHR® Universal Head Bipolar ComponentHowmedica Osteonics Corp., Dba Stryker OrthopaedicsK243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi CoatingNextstep Arthopedix, LLCK251270Taperloc® Complete Hip StemBiomet, 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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