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FDA 510(k)

ETEX HIP REPLACEMENT SYSTEM

K-Number: K925895 · 1993-02-09

ApplicantEtex Co.
Decision Date1993-02-09
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ETEX HIP REPLACEMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Etex Co.. It received FDA 510(k) clearance on 1993-02-09 under 510(k) number K925895. The device is classified under product code JDI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ETEX HIP REPLACEMENT SYSTEM?

ETEX HIP REPLACEMENT SYSTEM is a medical device that received FDA 510(k) clearance on 1993-02-09. The listed applicant is Etex Co.. The 510(k) number is K925895.

When did ETEX HIP REPLACEMENT SYSTEM receive FDA 510(k) clearance?

ETEX HIP REPLACEMENT SYSTEM received FDA 510(k) clearance on 1993-02-09, under 510(k) number K925895.

Who is the listed applicant for ETEX HIP REPLACEMENT SYSTEM?

The FDA 510(k) record lists Etex Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ETEX HIP REPLACEMENT SYSTEM?

The FDA product code for ETEX HIP REPLACEMENT SYSTEM is JDI.

Related Clinical Trials

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.

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Other records listing Etex Co. 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.

K913417ETEX DENTAL IMPLANT SYSTEM

Related Devices (Code: JDI)

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.

K253515Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and AugmentsBiomet Orthopedics, Inc.K253434OSSTM Orthopedic Salvage SystemBiomet, Inc.K243571Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained LinersZimmer BiometK240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip StemsSmith & Nephew, Inc.K241716Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee ComponentHowmedica Osteonics Corp., Dba Stryker OrthopaedicsK240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics

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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