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FDA 510(k)

HA GLOBAL TAPER (GT) TAPERED HIP STEM

K-Number: K970337 · 1997-02-28

ApplicantSmith & Nephew, Inc., Orthopaedic Div.
Decision Date1997-02-28
Product CodeMEH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HA GLOBAL TAPER (GT) TAPERED HIP STEM is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew, Inc., Orthopaedic Div.. It received FDA 510(k) clearance on 1997-02-28 under 510(k) number K970337. The device is classified under product code MEH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HA GLOBAL TAPER (GT) TAPERED HIP STEM?

HA GLOBAL TAPER (GT) TAPERED HIP STEM is a medical device that received FDA 510(k) clearance on 1997-02-28. The listed applicant is Smith & Nephew, Inc., Orthopaedic Div.. The 510(k) number is K970337.

When did HA GLOBAL TAPER (GT) TAPERED HIP STEM receive FDA 510(k) clearance?

HA GLOBAL TAPER (GT) TAPERED HIP STEM received FDA 510(k) clearance on 1997-02-28, under 510(k) number K970337.

Who is the listed applicant for HA GLOBAL TAPER (GT) TAPERED HIP STEM?

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

What is the FDA product code for HA GLOBAL TAPER (GT) TAPERED HIP STEM?

The FDA product code for HA GLOBAL TAPER (GT) TAPERED HIP STEM is MEH.

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Other records listing Smith & Nephew, Inc., Orthopaedic Div. 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.

K991538OPERA CUPFLANGED ACETABULAR COMPONENTSK970635TITANIUM SPINAL ROD SYSTEMK971414ZIRCONIA PROZYR CERAMIC 12/14 GLOBAL TAPER (GT) FEMORAL HEADSK970748TAYLOR SPATIAL FRAME EXTERNAL FIXATION SYSTEMK970751HEIDELBERG EXTERNAL FIXATORK970713COMPASS UNIVERSAL HINGE

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Related Devices (Code: MEH)

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.

K261576Icona Hip StemCorin, Ltd.K250375Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KGK251166Mfinity Femoral SystemMedacta International S.A.K251052Trivicta® Hip StemOrtho Development Corp.K242315Resolve Modular Revision Hip StemUnited Orthopedic CorporationK243839Alteon® HA Femoral StemsExactech, 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.

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