FDA 510(k)

GLOBAL TAPER TAPERED HIP SYSTEM, GT SPECTRON

K-Number: K963509 · 1997-01-27

Decision Date1997-01-27

Product CodeLPH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

GLOBAL TAPER TAPERED HIP SYSTEM, GT SPECTRON 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 1997-01-27 under 510(k) number K963509. 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 GLOBAL TAPER TAPERED HIP SYSTEM, GT SPECTRON?

GLOBAL TAPER TAPERED HIP SYSTEM, GT SPECTRON is a medical device that received FDA 510(k) clearance on 1997-01-27. The listed applicant is Smith & Nephew Richards, Inc.. The 510(k) number is K963509.

When did GLOBAL TAPER TAPERED HIP SYSTEM, GT SPECTRON receive FDA 510(k) clearance?

GLOBAL TAPER TAPERED HIP SYSTEM, GT SPECTRON received FDA 510(k) clearance on 1997-01-27, under 510(k) number K963509.

Who is the listed applicant for GLOBAL TAPER TAPERED HIP SYSTEM, GT SPECTRON?

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 GLOBAL TAPER TAPERED HIP SYSTEM, GT SPECTRON?

The FDA product code for GLOBAL TAPER TAPERED HIP SYSTEM, GT SPECTRON is LPH.

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

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Related Devices (Code: LPH)

K261453G7® Acetabular SystemZimmer Biomet K253630Mpact 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 Orthopaedics K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi CoatingNextstep Arthopedix, LLC K251270Taperloc® Complete Hip StemBiomet, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.