FDA.report

510(k) K081351

Device
MODIFICATION TO JOURNEY UNICONDYLAR FEMORAL IMPLANT
Applicant
SMITH & NEPHEW, INC.
510(k) number
K081351
Product code
HSX  
Decision
Substantially Equivalent (SESE)
Decision date
2008-07-24
Date received
2008-05-14
Regulation
888.3520
Classification name
Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
NICHOLAS B TABRIZI
Address
1450 E. Brooks Rd. Memphis TN US 38116 38116

FDA Registration Numbers

Source Documents

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

Legacy Summary

summary

FDA Review

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