FDA.report

510(k) K042515

Device
SMITH & NEPHEW, INC. HIGH PERFORMANCE KNEE
Applicant
SMITH & NEPHEW, INC.
510(k) number
K042515
Product code
JWH  
Decision
Substantially Equivalent (SESE)
Decision date
2005-03-14
Date received
2004-09-16
Regulation
888.3560
Classification name
Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Abbreviated
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
JANET JOHNSON AKIL
Address
1450 Brooks Rd. Memphis TN US 38116 38116

FDA Registration Numbers

Source Documents

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

Related GUDID Devices

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03596010554611JOURNEYSmith & Nephew, Inc.2015-10-05
03596010554628JOURNEYSmith & Nephew, Inc.2015-10-05
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03596010554703JOURNEYSmith & Nephew, Inc.2015-09-28
03596010554666JOURNEYSmith & Nephew, Inc.2015-09-28
03596010559265JOURNEYSmith & Nephew, Inc.2015-09-28
03596010554635JOURNEYSmith & Nephew, Inc.2015-09-28
03596010559241JOURNEYSmith & Nephew, Inc.2015-09-28
03596010554796JOURNEYSmith & Nephew, Inc.2015-09-28
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03596010554727JOURNEYSmith & Nephew, Inc.2015-09-28
03596010554789JOURNEYSmith & Nephew, Inc.2015-09-28
03596010554710JOURNEYSmith & Nephew, Inc.2015-09-28
03596010554840JOURNEYSmith & Nephew, Inc.2015-09-28
03596010554802JOURNEYSmith & Nephew, Inc.2015-09-28
03596010554697JOURNEYSmith & Nephew, Inc.2015-09-28
03596010554598JOURNEYSmith & Nephew, Inc.2015-09-28
03596010554574JOURNEYSmith & Nephew, Inc.2015-09-28
03596010554673JOURNEYSmith & Nephew, Inc.2015-09-28
03596010559197JOURNEYSmith & Nephew, Inc.2015-09-28
03596010554734JOURNEYSmith & Nephew, Inc.2015-09-28
03596010554833JOURNEYSmith & Nephew, Inc.2015-09-28
03596010554642JOURNEYSmith & Nephew, Inc.2015-09-28
03596010554604JOURNEYSmith & Nephew, Inc.2015-09-28
03596010554819JOURNEYSmith & Nephew, Inc.2015-09-28
03596010554772JOURNEYSmith & Nephew, Inc.2015-09-28
03596010554680JOURNEYSmith & Nephew, Inc.2015-09-28

Legacy Summary

summary

FDA Review

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