Since the beginning of 2023, 16 new devices created by medical device company Medtronic have secured 510(k) clearance from the FDA, including several spinal and orthopedic devices.
The 16 new Medtronic devices earning FDA clearance through September 2023, according to records from FDA.gov:
January
Infinity OCT system
CD Horizon Spinal system
March
ClosureFast Endovenous Radiofrequency Ablation Catheter
April
Tubing and Accessories Sets for Extracorporeal Membrane Oxygenation with Balance Biosurface
Reveal LINQ Insertable Cardiac Monitor, LINQ II Insertable Cardiac Monitor, AccuRhythm AI ECG Classification System
LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM Application
Affinity Fusion Oxygenator System
May
DLP Silicone Coronary Artery Ostial Cannulae
CD Horizon Spinal System
June
5F Launcher Guide Catheter, 6F Launcher Guide Catheter, 7F Launcher Guide Catheter, 8F Launcher Guide Catheter
PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E
Zevo Anterior Cervical Plate System
July
Robotic Graft Delivery Instruments
August
NIM 35cm long Surgeon Control Probe, 1mm Ball-Tip
CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System
6F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide Catheter