Medtronic - FDA 510(k) Cleared Devices
Recent clearances: Trexon™ Monofilament Synthetic Absorbable Suture, Affinity Pixie™ Arterial Filter with Balance™ Biosurface, Sphere-9Dx Diagnostic Catheter (AFR-00009)
33
Total
33
Cleared
0
Denied
FDA 510(k) Regulatory Record - Medtronic Orthopedic ✕
12 devices
Cleared
Jan 23, 2023
CD Horizon Spinal System
Orthopedic
63d
Cleared
May 25, 2022
CD Horizon™ Spinal System
Orthopedic
23d
Cleared
Jun 23, 2021
CD Horizon Spinal System
Orthopedic
30d
Cleared
Apr 30, 2021
CD Horizon™ Spinal System
Orthopedic
58d
Cleared
Mar 18, 2021
Infinity™ OCT System, PASS OCT® Spinal System
Orthopedic
30d
Cleared
Oct 19, 2020
CD Horizon Spinal System
Orthopedic
28d
Cleared
Aug 19, 2020
CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™...
Orthopedic
89d
Cleared
Oct 23, 2017
KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw Set
Orthopedic
117d
Cleared
Nov 16, 2015
KYPHON XPEDE Bone Cement
Orthopedic
193d
Cleared
Dec 21, 2012
KYPHON EXPRESS II INFLATABLE BONE TAMPS
Orthopedic
14d
Cleared
Feb 28, 2011
KYPHON XPEDE BONE CEMENT
Orthopedic
188d
Cleared
Oct 14, 2010
KYPHON XPANDER II INFLATABLE BONE TAMP
Orthopedic
104d