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510(k) K100048

Device
E1 ANTIOXIDANT INFUSED TECHNOLOGY
Applicant
BIOMET MANUFACTURING CORP.
510(k) number
K100048
Product code
OIY  
Decision
Substantially Equivalent (SESE)
Decision date
2010-03-09
Date received
2010-01-08
Regulation
888.3560
Classification name
Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer + Additive/metal/polymer + Additive
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
BECKY EARL
Address
P.O. Box 587 Warsaw IN US 46581 46581

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code OIY  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K252887DePuy ATTUNE™ Knee SystemDePuy Orthopaedics, Inc.2026-05-22
K242665DePuy ATTUNE™ Total Knee SystemDepuy Orthopedics, Inc.2024-11-01
K201347DePuy ATTUNE™ Total Knee SystemDePuy Orthopaedics, Inc.2020-06-18
K120038A200 KNEE SYSTEMRenovis Surgical Technologies, LLC2013-02-14
K121727MOVATION KNEE SYSTEMEncore Medical L.P.2012-08-15
K113756HIGHLY CROSS LINKED VE CENTRAL PEG PATELLA HIGHLY CROSS LINKED VE TRI-PEG PATELLA HIGHLY CROSS LINKED VE METAL BACKED PAEncore Medical L.P.2012-03-14
K111433DEPUY STTUNE (TM) PS KNEE SYSTEMDePuy Orthopaedics, Inc.2011-08-30
K103756DEPUY ATTUNE TOTAL KNEE SYSTEMDePuy Orthopaedics, Inc.2011-03-15
K103223HIGHLY CROSS-LINKED VITAMIN E UHMWPE TIBIAL INSERTSEncore Medical L.P.2010-12-21
K101433DEPUY ATTUNE KNEE SYSTEMDePuy Orthopaedics, Inc.2010-12-10
K091956HIGHLY CROSS-LINKED VITAMIN E UHMWPE TIBIAL INSERTS, MODEL 391/392-09_19-702_712Encore Medical L.P.2010-09-28

Legacy Summary#

summary

FDA Review#

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