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510(k) K960538

Device
OPTEON UNIPOLAR
Applicant
EXACTECH, INC.
510(k) number
K960538
Product code
KWL  
Decision
Substantially Equivalent (SESE)
Decision date
1996-03-27
Date received
1996-02-07
Regulation
888.3360
Classification name
Prosthesis, Hip, Hemi-, Femoral, Metal
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
MARTHA C MILLER
Address
4613 NW 6th St., Suite D Gainesville FL US 32609 32609

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KWL  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K260536Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone CementDepuy Ireland UC2026-05-15
K253675OsteoRemedies Hip Spacer SystemOsteoremedies, LLC2025-12-23
K252326InterSpace GV Hip SpacerTecres S.P.A.2025-08-06
K242865Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder SpacerBiocomposites, Ltd.2025-06-12
K234028COPAL® exchange G hip spacer; COPAL® G+VHeraeus Medical GmbH2024-02-15
K222632UHR Bipolar Implants, Restoration GAP II ImplantsHowmedica Osteonics Corp., Dba Stryker Orthopaedics2022-10-21
K192995OsteoRemedies Hip Spacer SystemOsteoremedies, LLC2020-01-10
K191981REMEDY Acetabular CupOsteoremedies, LLC2019-08-23
K172906REMEDY PLUS Hip Spacer, UNITE PLUS Bone CementOsteoremedies, LLC2018-08-29
K173967Remedy Acetabular CupOsteoremedies, LLC2018-02-22
K143184Evolve UniPolar HeadSignature Orthopaedics Pty, Ltd.2015-03-17
K1124702GC HIP/KNEE MODULAR SPACERMandell Horwitz Consultants, LLC2012-04-05
K101356Spacer-G and Spacer-KTecres S.P.A.2011-09-20
K111911CORIN OPTIMOM MODULAR HEADCorin USA2011-08-04
K062273SPACER-G TEMPORARY HIP PROSTHESISTecres S.P.A.2008-05-22

Legacy Summary#

summary

FDA Review#

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