FDA.report

510(k) K211612

Device
Medline UNITE REFLEX Dynamic Discs
Applicant
Medline Industries, Inc.
510(k) number
K211612
Product code
HTN  
Decision
Substantially Equivalent (SESE)
Decision date
2021-12-10
Date received
2021-05-26
Regulation
888.3030
Classification name
Washer, Bolt Nut
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
Three Lakes Dr. Northfiled IL US 60093 60093

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Legacy Summary

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FDA Review

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