Medical Device Manufacturer · US , Waltham , MA

Augmenix, Inc.

5 submissions · 4 cleared · Since 2013
5
Total
4
Cleared
1
Denied

Augmenix, Inc. — FDA 510(k) Submissions

Augmenix, Inc. has submitted 5 FDA 510(k) premarket notifications since 2013, of which 4 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Hydrogel Spacer, Marker, Radiographic, Implantable . Use the specialty filter in the sidebar to narrow results.

5 devices
1–5 of 5
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All5 Radiology 3 General & Plastic Surgery 2