FDA.report

510(k) K980926

Device
DURATION II ACETABULAR COMPONENTS-ETHYLENE OXIDE STERILIZATION
Applicant
HOWMEDICA CORP.
510(k) number
K980926
Product code
JDI  
Decision
Substantially Equivalent (SESE)
Decision date
1998-12-16
Date received
1998-03-11
Regulation
888.3350
Classification name
Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
MARGARET F CROWE
Address
359 Veterans Blvd. Rutherford NJ US 07070 07070

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Other 510(k) Records For Product Code JDI  

510(k)DeviceApplicantDecision date
K243571Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained LinersZimmer Biomet2025-07-31
K240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip StemsSmith & Nephew, Inc.2024-10-21
K241716Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee ComponentHowmedica Osteonics Corp., Dba Stryker Orthopaedics2024-08-02
K240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics2024-04-12
K233261Global Modular Replacement SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics2023-12-08
K222056Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge KneeHowmedica Osteonics Corp., Dba Stryker Orthopaedics2023-01-26
K220216C-Stem AMT LE ProsthesisDepuy Ireland UC2022-07-22
K213701Exeter® X3® RimFit® CupHowmedica Osteonics Corp., Dba Stryker Orthopaedics2022-02-01
K213816MPO Hip InstrumentsMicroport Orthopedics, Inc.2022-01-05
K210842VerSys Cemented Revision/CalcarZimmer, Inc.2021-12-10
K203815ELEOS Limb Salvage System with BioGripOnkos Surgical2021-06-09
K203588ELEOS™ Limb Salvage SystemOnkos Surgical2021-02-05
K203090ELEOS Limb Salvage System featuring BIOGRIPOnkos Surgical2020-12-11
K201519PROFEMUR® GLADIATOR® Cemented Classic StemMicroport Orthopedics, Inc.2020-12-10
K193429Exeter V40 Femoral Stem, Exeter X3 RimFit CupHowmedica Osteonics Corp.2020-08-13

Legacy Summary

summary

FDA Review

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