FDA.report

510(k) K250628

Device
DynaNail TTC Fusion System
Applicant
MedShape, Inc.
510(k) number
K250628
Product code
HSB
Decision
Substantially Equivalent (SESE)
Decision date
2025-09-12
Date received
2025-03-03
Regulation
888.3020
Classification name
Rod, Fixation, Intramedullary And Accessories
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Amberlee Soto
Address
1575 Northside Dr. NW Suite 440 Atlanta GA US 30318 30318

FDA Registration Numbers

Source Documents

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

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