FDA.report

510(k) K221323

Device
Exactech® Alteon® Short Tapered Wedge
Applicant
Exactech, Inc.
510(k) number
K221323
Product code
LZO
Decision
Substantially Equivalent (SESE)
Decision date
2023-05-19
Date received
2022-05-06
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
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Valdimir Talley
Address
2320 NW 66th Ct. Gainesville FL US 32653 32653

FDA Registration Numbers

Source Documents

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

Related GUDID Devices

Primary DIBrandCompanyPublished
10885862595065AlteonExactech, Inc.2025-04-30
10885862595034AlteonExactech, Inc.2025-04-30
10885862595003AlteonExactech, Inc.2025-04-30
10885862595010AlteonExactech, Inc.2025-04-30
10885862595027AlteonExactech, Inc.2025-04-30
10885862594952AlteonExactech, Inc.2025-04-30
10885862594945AlteonExactech, Inc.2025-04-30
10885862594938AlteonExactech, Inc.2025-04-30
10885862594921AlteonExactech, Inc.2025-04-30
10885862594914AlteonExactech, Inc.2025-04-30
10885862594907AlteonExactech, Inc.2025-04-30
10885862594891AlteonExactech, Inc.2025-04-30
10885862595140AlteonExactech, Inc.2025-04-30
10885862594969AlteonExactech, Inc.2025-04-30
10885862595058AlteonExactech, Inc.2025-04-30
10885862595041AlteonExactech, Inc.2025-04-30
10885862595072AlteonExactech, Inc.2025-04-30
10885862595089AlteonExactech, Inc.2025-04-30
10885862595096AlteonExactech, Inc.2025-04-30
10885862595102AlteonExactech, Inc.2025-04-30
10885862595119AlteonExactech, Inc.2025-04-30
10885862595126AlteonExactech, Inc.2025-04-30
10885862595133AlteonExactech, Inc.2025-04-30
10885862595157AlteonExactech, Inc.2025-04-30
10885862595164AlteonExactech, Inc.2025-04-30
10885862595171AlteonExactech, Inc.2025-04-30
10885862595188AlteonExactech, Inc.2025-04-30
10885862595195AlteonExactech, Inc.2025-04-30
10885862595201AlteonExactech, Inc.2025-04-30
10885862595218AlteonExactech, Inc.2025-04-30

Other 510(k) Records For Product Code LZO

510(k)DeviceApplicantDecision date
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
K250834Zimmer Biomet Ceramic Heads (22.2mm diameter)Zimmer Biomet2025-04-18
K250571CATALYSTEM Femoral StemsSmith & Nephew, Inc.2025-03-28
K243029Origin™ TT StemSignature Orthopaedics Pty, Ltd.2025-03-11
K241767Versacem Acetabular Shell and Double Mobility HC LinersMedacta International S.A.2025-03-06