FDA.report

510(k) K933494

Device
EXACTECH POSTERIOR STABILIZED CEMENTED TOTAL KNEE SYSTEM
Applicant
EXACTECH, INC.
510(k) number
K933494
Product code
JWH  
Decision
Substantially Equivalent For Some Indications (SN)
Decision date
1995-03-10
Date received
1993-07-19
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
Traditional
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
TIMOTHY J SEESE
Address
4613 NW 6th St., Suite D Gainesville FL US 32609 32609

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF not indicated by FDA · openFDA JSON

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10885862047960OptetrakExactech, Inc.2015-10-30
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Legacy Summary

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FDA Review

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