FDA.report

510(k) K162829

Device
Medline UNITE® Ankle Fracture Plating System
Applicant
MEDLINE, INDUSTRIES, INC.
510(k) number
K162829
Product code
HRS  
Decision
Substantially Equivalent (SESE)
Decision date
2016-12-09
Date received
2016-10-07
Regulation
888.3030
Classification name
Plate, Fixation, Bone
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
Jennifer Mason
Address
One Medline Pl. Mundelein IL US 60060 60060

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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