FDA.report

510(k) K083432

Device
DRILL FREE MMF SCREW
Applicant
KLS MARTIN L.P.
510(k) number
K083432
Product code
DZL  
Decision
Substantially Equivalent (SESE)
Decision date
2009-03-31
Date received
2008-11-20
Regulation
872.4880
Classification name
Screw, Fixation, Intraosseous
Medical specialty
Dental
Review panel
Dental
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
TOM FAUCET
Address
11239 St. Johns Industrial Pkwy. S. Jacksonville FL US 32246 32246

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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