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510(k) K982032

Device
OSTEONICS OMNIFIT HA HIP STEM SERIES, OSTEONICS SECUR-FIT HA HIP STEM SERIES, OSTEONICS PRIMARY SECUR-FIT PLUS HIP STEMS
Applicant
OSTEONICS CORP.
510(k) number
K982032
Product code
MEH  
Decision
Substantially Equivalent (SESE)
Decision date
1998-07-09
Date received
1998-06-10
Regulation
888.3353
Classification name
Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
KATE SUTTON
Address
59 Rte. 17 Allendale NJ US 07401 07401

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MEH  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K261576Icona Hip StemCorin, Ltd.2026-08-10
K250375Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KG2025-11-05
K251166Mfinity Femoral SystemMedacta International S.A.2025-06-13
K251052Trivicta® Hip StemOrtho Development Corp.2025-05-22
K242315Resolve Modular Revision Hip StemUnited Orthopedic Corporation2025-05-01
K243839Alteon® HA Femoral StemsExactech, Inc.2025-03-10
K243162World LinerSignature Orthopaedics Pty, Ltd.2024-11-25
K241472Icona Hip StemCorin U.S.A. Limited2024-10-03
K241875TheRay Collared and Collarless Femoral StemNextstep Arthropedix2024-09-13
K241690Logical Liner; World Liner; World Knee PatellaSignature Orthopaedics Pty, Ltd.2024-08-01
K233758Trivicta™ Hip StemOrtho Development Corp.2024-03-08
K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip Prosthesis – MR Conditional, DePuy SUMMIT Cemented Hip Prosthesis – MR Conditional, DePuy SUMMIT FX Cemented Hip Prosthesis – MR Conditional, DePuy SUMMIT Basic Press-Fit Hip Prosthesis – MR ConditionalDepuy Ireland UC2024-01-19
K231178ACTERA™ hip systemConformis, Inc.2023-05-23
K220495SignaSure Dual Mobility SystemSignature Orthopaedics Pty, Ltd.2023-01-13
K220731Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker2022-08-11

Legacy Summary#

summary

FDA Review#

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