K2m, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
K2m, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Q Pedicle Instruments, Vulcan Spinal System, Q Interbody Instruments
100
Total
97
Cleared
0
Denied
K2m, Inc. has 97 FDA 510(k) cleared orthopedic devices. Based in Leesburg, US.
Latest FDA clearance: Mar 2026. Active since 2007.
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 Stryker, Backroads Consulting, Inc. and K2m.
FDA 510(k) Regulatory Record - K2m, Inc.
100 devices
Cleared
Mar 17, 2026
Q Pedicle Instruments
Orthopedic
27d
Cleared
Feb 10, 2026
Vulcan Spinal System
Orthopedic
88d
Cleared
Feb 06, 2026
Q Interbody Instruments
Orthopedic
149d
Cleared
Feb 24, 2022
CAPRI Corpectomy Cage System
Orthopedic
300d
Cleared
Oct 26, 2020
Cannulated Power Driver Attachment
Orthopedic
55d
Cleared
Aug 07, 2020
K2M Navigation Instruments
Orthopedic
112d
Cleared
Feb 18, 2020
MOJAVE Expandable Interbody System
Orthopedic
90d
Cleared
Feb 07, 2020
Yukon OCT Spinal System
Orthopedic
87d
Cleared
Nov 14, 2019
Brainlab Compatible K2M Navigation Instruments
Orthopedic
30d
Cleared
Oct 03, 2019
SAHARA Stabilization System
Orthopedic
244d
Cleared
May 15, 2019
CAYMAN LP Plate System
Orthopedic
70d
Cleared
Dec 12, 2018
PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK...
Orthopedic
93d
Looking for a specific device from K2m, Inc.? Search by device name or K-number.
Search all K2m, Inc. devices