FDA.report

510(k) K113650

Device
ORTHOFIX SCREW
Applicant
BONAFIX SURGICAL AND DENTAL IMPLANTS, LLC
510(k) number
K113650
Product code
OAT  
Decision
Substantially Equivalent (SESE)
Decision date
2012-10-03
Date received
2011-12-12
Regulation
872.3640
Classification name
Implant, Endosseous, Orthodontic
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
JUAN TEZAK
Address
118 W Prive Cr. 118 W Prive Cr. FL US 33445 33445

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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