Wenzel Spine, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Wenzel Spine, Inc. - FDA 510(k) Cleared Devices
Recent clearances: panaSIa SI Fusion System, VariLift®-C Interbody Fusion System, primaLOK™ SP Interspinous Fusion System
6
Total
6
Cleared
0
Denied
Wenzel Spine, Inc. has 6 FDA 510(k) cleared medical devices. Based in Austin, US.
Latest FDA clearance: Jul 2025. Active since 2013. Primary specialty: Orthopedic.
Browse the FDA 510(k) cleared devices submitted by Wenzel Spine, Inc. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Mcra, LLC as regulatory consultant.
FDA 510(k) Regulatory Record - Wenzel Spine, Inc.
6 devices
Cleared
Jul 09, 2025
panaSIa SI Fusion System
Orthopedic
163d
Cleared
Sep 27, 2023
VariLift®-C Interbody Fusion System
Orthopedic
166d
Cleared
Aug 15, 2023
primaLOK™ SP Interspinous Fusion System
Orthopedic
56d
Cleared
Jan 28, 2019
VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion System
Orthopedic
304d
Cleared
Dec 11, 2015
VariLift-L Interbody Fusion Device
Orthopedic
154d
Cleared
Sep 03, 2013
VARILIFT-L INTERBODY FUSION DEVICE
Orthopedic
120d