FDA.report

510(k) K030301

Device
UNICONDYLAR FEMORAL COMPONENT
Applicant
SMITH & NEPHEW, INC.
510(k) number
K030301
Product code
JWH  
Decision
Substantially Equivalent (SESE)
Decision date
2003-02-25
Date received
2003-01-29
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
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
KIM KELLY
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

Primary DIBrandCompanyPublished
03596010483782OXINIUMSmith & Nephew, Inc.2015-08-29
03596010483775OXINIUMSmith & Nephew, Inc.2015-08-29
03596010483768OXINIUMSmith & Nephew, Inc.2015-08-29
03596010483751OXINIUMSmith & Nephew, Inc.2015-08-29
03596010483744OXINIUMSmith & Nephew, Inc.2015-08-29
03596010483737OXINIUMSmith & Nephew, Inc.2015-08-29

Legacy Summary

summary

FDA Review

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases