Orthocell, Ltd. is one of 80 FDA 510(k) medical device manufacturers from Australia in the dataset, ranked by real submission volume.
Orthocell, Ltd. - FDA 510(k) Cleared Devices
Recent clearances: Remplir (ON-152, 15 x 20 mm), Striate+™
2
Total
2
Cleared
0
Denied
Orthocell, Ltd. has 2 FDA 510(k) cleared medical devices. Based in Perth, AU.
Latest FDA clearance: Apr 2025. Active since 2021. Primary specialty: Dental.
Browse the FDA 510(k) cleared devices submitted by Orthocell, Ltd. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Hogan Lovells US LLP as regulatory consultant.
FDA 510(k) Regulatory Record - Orthocell, Ltd.
2 devices