Medical Device Manufacturer · US , Fenton , MI

Omega Surgical Instruments, Inc.

3 submissions · 3 cleared · Since 1993
3
Total
3
Cleared
0
Denied

Omega Surgical Instruments, Inc. — FDA 510(k) Submissions

Omega Surgical Instruments, Inc. has submitted 3 FDA 510(k) premarket notifications since 1993, of which 3 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Blade, Saw, General & Plastic Surgery, Surgical, Pin, Fixation, Smooth . Use the specialty filter in the sidebar to narrow results.

3 devices
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All3 General & Plastic Surgery 2 Orthopedic 1