FDA.report

510(k) K183228

Device
HammerToe Compression System
Applicant
Paragon 28, Inc.
510(k) number
K183228
Product code
HTY  
Decision
Substantially Equivalent (SESE)
Decision date
2019-01-25
Date received
2018-11-20
Regulation
888.3040
Classification name
Pin, Fixation, Smooth
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
Eric Lintula
Address
4b Inverness Ct. E, Suite 280 Englewood CO US 80112 80112

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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