FDA.report

510(k) K973453

Device
TORNIER CEMENT RESTRICTOR
Applicant
TORNIER
510(k) number
K973453
Product code
JDI  
Decision
Substantially Equivalent (SESE)
Decision date
1997-12-09
Date received
1997-09-11
Regulation
888.3350
Classification name
Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
DAVID W SCHLERF
Address
1000 Burnett Ave., Suite 450 Concord CA US 94520 94520

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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