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FDA 510(k)

Exeter V40 Femoral Stem, Exeter X3 RimFit Cup

K-Number: K193429 · 2020-08-13

ApplicantHowmedica Osteonics Corp.
Decision Date2020-08-13
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Exeter V40 Femoral Stem, Exeter X3 RimFit Cup is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Osteonics Corp.. It received FDA 510(k) clearance on 2020-08-13 under 510(k) number K193429. 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 Exeter V40 Femoral Stem, Exeter X3 RimFit Cup?

Exeter V40 Femoral Stem, Exeter X3 RimFit Cup is a medical device that received FDA 510(k) clearance on 2020-08-13. The listed applicant is Howmedica Osteonics Corp.. The 510(k) number is K193429.

When did Exeter V40 Femoral Stem, Exeter X3 RimFit Cup receive FDA 510(k) clearance?

Exeter V40 Femoral Stem, Exeter X3 RimFit Cup received FDA 510(k) clearance on 2020-08-13, under 510(k) number K193429.

Who is the listed applicant for Exeter V40 Femoral Stem, Exeter X3 RimFit Cup?

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

What is the FDA product code for Exeter V40 Femoral Stem, Exeter X3 RimFit Cup?

The FDA product code for Exeter V40 Femoral Stem, Exeter X3 RimFit Cup is JDI.

Other records listing Howmedica Osteonics Corp. 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.

PMA P000013Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncementedK200782Triathlon Posterior Stabilized Femoral Component - beaded with Peri-Apatite, Triathlon Cruciate Retaining Femoral Component - beaded with Peri-Apatite

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.

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 OrthopaedicsK233261Global Modular Replacement SystemHowmedica Osteonics Corp. A.K.A. 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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