Medartis AG is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Medartis AG - FDA 510(k) Cleared Devices
Recent clearances: APTUS Clavicle System 2.8, TITAN Nail, APTUS Shoulder Proximal Humerus System, PentaLock 3.5
42
Total
42
Cleared
0
Denied
Medartis AG has 42 FDA 510(k) cleared orthopedic devices. Based in San Diego, US.
Latest FDA clearance: Jun 2026. Active since 1999.
Browse the complete list of FDA 510(k) cleared orthopedic devices from this manufacturer. Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by PaxMed International, LLC and Medartis, Inc..
FDA 510(k) Regulatory Record - Medartis AG
42 devices
Cleared
Jun 05, 2026
APTUS Clavicle System 2.8
Orthopedic
88d
Cleared
Apr 17, 2026
TITAN Nail
Orthopedic
28d
Cleared
Mar 16, 2026
APTUS Shoulder Proximal Humerus System, PentaLock 3.5
Orthopedic
98d
Cleared
Mar 07, 2025
APTUS Hand System
Orthopedic
105d
Cleared
Jun 20, 2024
APTUS Elbow Dorsal Olecranon Plates
Orthopedic
107d
Cleared
Apr 19, 2024
APTUS Foot System 2.8-3.5
Orthopedic
280d
Cleared
Mar 21, 2024
APTUS Hand Scaphoid Plates
Orthopedic
90d
Cleared
Nov 03, 2023
APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line...
Orthopedic
98d
Cleared
Aug 18, 2023
Sterile Products of the APTUS System
Orthopedic
30d
Cleared
Jun 02, 2023
APTUS® 3.5 TriLock Straight Plates
Orthopedic
58d
Cleared
Mar 30, 2023
Medartis APTUS® Ulna Plates
Orthopedic
97d
Cleared
Nov 06, 2020
APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression...
General Hospital
59d
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