Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Howmedica Osteonics Corp.. It received FDA 510(k) clearance on 2020-08-13 under approval 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. It is manufactured by Howmedica Osteonics Corp.. The 510(k) number is K193429.

When was Exeter V40 Femoral Stem, Exeter X3 RimFit Cup approved by the FDA?

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

What company makes Exeter V40 Femoral Stem, Exeter X3 RimFit Cup?

Exeter V40 Femoral Stem, Exeter X3 RimFit Cup is manufactured by Howmedica Osteonics Corp..

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 Devices by Howmedica Osteonics Corp.

K200782Triathlon Posterior Stabilized Femoral Component - beaded with Peri-Apatite, Triathlon Cruciate Retaining Femoral Component - beaded with Peri-Apatite PMA P000013Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented

Related Devices (Code: JDI)

K160923REDAPT Anteverted Cemented LinerSmith & Nephew, Inc. K153057FitRite™ Total Hip Arthroplasty SystemExcera Orthopedics, Inc. K153725Corin TaperFit Hip StemCorin U.S.A. Limited K153216Alpine Cemented Hip SystemOrtho Development Corporation K162125MALUC™ Total Hip Arthroplasty SystemSurgtech, Inc. K180973Libertas Hip Replacement SystemMaxx Orthopedics, 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.

↑