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510(k) K163441

Device
Locking Cage, Full XPE Cup
Applicant
UNITED ORTHOPEDIC CORPORATION
510(k) number
K163441
Product code
LZO  
Decision
Substantially Equivalent (SESE)
Decision date
2017-08-25
Date received
2016-12-08
Regulation
888.3353
Classification name
Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
GIMPEL CHIEN
Address
No 57, Park Ave. 2, Science Park Hsinchu TW 300 300

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LZO  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.2026-09-17
K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation2026-09-02
K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG2026-07-06
K260831Z1 Hip SystemZimmer, Inc.2026-06-16
K260182Avenir® Müller Stem; Avenir Complete™ Hip SystemZimmer, Inc.2026-04-27
K260037implantcast Packaging System UpdateImplantcast GmbH2026-03-30
K252401implaFit® short stemsImplantcast GmbH2026-03-12
K253171Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)Maxx Orthopedics, Inc.2026-01-15
K250450Coated hip implantsMedacta International S.A.2025-09-19
K243021Longboard Revision Hip StemSignature Orthopaedics Pty, Ltd.2025-08-07
K251906Z1 Hip SystemZimmer, Inc.2025-07-18
K251292RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC2025-05-23
K243927MobileLink Acetabular Cup System - inhouse coatingsWaldemar Link GmbH & Co. KG2025-05-16
K250444NEXUS® Hip StemMicroport Orthopedics, Inc.2025-05-15
K243043Origin™ Cemented Hip StemSignature Orthopaedics Pty, Ltd.2025-05-02

Legacy Summary#

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FDA Review#

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