Medical Device Manufacturer · US , Austin , TX

Wenzel Spine, Inc. - FDA 510(k) Cleared Devices

6 submissions · 6 cleared · Since 2013

Recent clearances: panaSIa SI Fusion System, VariLift®-C Interbody Fusion System, primaLOK™ SP Interspinous Fusion System

6
Total
6
Cleared
0
Denied

FDA 510(k) Regulatory Record - Wenzel Spine, Inc. Orthopedic ✕

6 devices
1-6 of 6
Cleared Jul 09, 2025
panaSIa SI Fusion System
K250247 · OUR
Orthopedic · 163d
Cleared Sep 27, 2023
VariLift®-C Interbody Fusion System
K231076 · ODP
Orthopedic · 166d
Cleared Aug 15, 2023
primaLOK™ SP Interspinous Fusion System
K231807 · PEK
Orthopedic · 56d
Cleared Jan 28, 2019
VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion System
K180822 · MAX
Orthopedic · 304d
Cleared Dec 11, 2015
VariLift-L Interbody Fusion Device
K151900 · MAX
Orthopedic · 154d
Cleared Sep 03, 2013
VARILIFT-L INTERBODY FUSION DEVICE
K131296 · MAX
Orthopedic · 120d
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