Medical Device Manufacturer · AU , Perth

Orthocell, Ltd.

2 submissions · 2 cleared · Since 2021

Total

Cleared

Denied

Orthocell, Ltd. — FDA 510(k) Submissions

Orthocell, Ltd. has submitted 2 FDA 510(k) premarket notifications since 2021, of which 2 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Barrier, Animal Source, Intraoral, Cuff, Nerve . Use the specialty filter in the sidebar to narrow results.

2 devices

1–2 of 2

Remplir (ON-152, 15 x 20 mm); Remplir (ON-203, 20 x 30 mm); Remplir (ON-304, 30 x 40 mm); Remplir (ON-405, 40 x 50 mm)

K243889 · JXI Cuff, Nerve · Neurology

Apr 2025 105d

Striate+?

K201241 · NPL Barrier, Animal Source,... · Dental

Jan 2021 248d

Data Source

FDA 510(k) public files . 174,402 total devices indexed.

Orthocell, Ltd.

Orthocell, Ltd. — FDA 510(k) Submissions

Filters