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510(k) K993943

Device
ENCORE LINEAR POROUS COATED HIP WITH HA, ENCORE FOUNDATION POROUS HIP WITH HA, ENCORE REVELATION POROUS HIP WITH HA
Applicant
ENCORE ORTHOPEDICS, INC.
510(k) number
K993943
Product code
MEH  
Decision
Substantially Equivalent (SESE)
Decision date
2000-02-04
Date received
1999-11-19
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
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
DEBBIE DE LOS SANTOS
Address
9800 Metric Blvd. Austin TX US 78758 78758

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
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
K221104Actera™ hip systemConformis, Inc.2022-08-04

Legacy Summary#

summary

FDA Review#

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