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Wenzel Spine: FDA-registered device maker in Austin, TX, United States, 9 510(k) clearances

Name: Wenzel Spine FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Wenzel Spine is registered with the FDA (registration 3006172536) in Austin, TX, United States. It lists 7 device types. The FDA files 9 510(k) clearances under its listings, the newest dated July 9, 2025. 4 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3006172536
Address: 2535 Brockton Dr Ste 450, Austin, TX, United States, 78758
Owner or operator: Wenzel Spine, Inc. (10030760)
Roles: Specification developer
First device listed: September 21, 2010
Registered through: 2026
Brand names listed: PrimaLOK-FF Facet Fixation System, PrimaLOK-SP Interspinous Fusion System, Surgical Planning Software version 1.1, VMA 3, VariLift-A Interbody Fusion System, VariLift-C Interbody Fusion System, VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion System, panaSIa SI Fusion System

Devices it lists

Device	Product code	Class	Role	Source
Appliance, Fixation, Spinal Interlaminal	KWP	2	Specification developer	accessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, Cervical	ODP	2	Specification developer	accessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, Lumbar	MAX	2	Specification developer	accessdata.fda.gov
Sacroiliac Joint Fixation	OUR	2	Specification developer	accessdata.fda.gov
Spinous Process Plate	PEK	2	Specification developer	accessdata.fda.gov
System, Facet Screw Spinal Device	MRW	U	Specification developer	accessdata.fda.gov
System, Image Processing, Radiological	LLZ	2	Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
July 9, 2025	K250247	panaSIa SI Fusion System	OUR	Substantially Equivalent	Wenzel Spine, Inc.	accessdata.fda.gov
September 27, 2023	K231076	VariLift®-C Interbody Fusion System	ODP	Substantially Equivalent	Wenzel Spine, Inc.	accessdata.fda.gov
August 15, 2023	K231807	primaLOK SP Interspinous Fusion System	PEK	Substantially Equivalent	Wenzel Spine, Inc.	accessdata.fda.gov
January 28, 2019	K180822	VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion System	MAX	Substantially Equivalent	Wenzel Spine, Inc.	accessdata.fda.gov
November 8, 2017	K173247	Surgical Planning Software version 1.1	LLZ	Substantially Equivalent	Ortho Kinematics, Inc.	accessdata.fda.gov
August 25, 2017	K172327	VMA System version 3.0	LLZ	Substantially Equivalent	Ortho Kinematics, Inc.	accessdata.fda.gov
September 30, 2010	K102438	PRIMALOK FACET FIXATION SYSTEM	MRW	Substantially Equivalent	Osteomed LP	accessdata.fda.gov
August 17, 2010	K100354	PRIMAL OK INTERSPINOUS FUSION SYSTEM	KWP	Substantially Equivalent	Osteomed LP	accessdata.fda.gov
August 5, 2010	K100820	WENZEL SPINE VARILIFT INTERBODY FUSION SYSTEM	MAX	Substantially Equivalent	Wenzel Spine	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
May 23, 2018	80769	Class II	Ongoing	Vertebral Motion Analyzer (VMA), 2.3.250. Product System, image processing, radiological	This is to provide notification that, due to a software bug that has been corrected, the Radiological Read Report for the VMA test(s) contained an error.	accessdata.fda.gov
March 2, 2017	80771	Class II	Ongoing	Vertebral Motion Analyzer (VMA), 2.3.239 - 2.3.254. Product Usage: VMA software is a quantitative imaging software application intended to be used to process digital image files.	Ortho Kinematics notified customers that errors were contained in Radiological Read Report and VMA Report for the VMA test. The error resulted from an administrative error of VMA user account settings and has been fixed.	accessdata.fda.gov
January 11, 2017	80680	Class II	Ongoing	Vertebral Motion Analyzer (VMA) Version 2.3.252. VMA software is a quantitative imaging software application intended to be used to process digital image files.	Ortho Kinematics Inc. sent a Notice of Correction to Released Testing Results, Radiological Read Report for the Vertebral Motion Analyzer (VMA) test because it contained an error. The error occurred due to a software bug that has been corrected.	accessdata.fda.gov
August 12, 2016	80768	Class II	Ongoing	Vertebral Motion Analyzer (VMA), VMA DataLink Software.2.3.231, 2.3.232. Product Usage: VMA software is a quantitative imaging software application intended to be used to process digital image files.	Ortho Kinematics, Inc. notified customers of erroneous results of VMA tests due to a software bug that has been corrected.	accessdata.fda.gov

Compare with other makers

Updated July 9, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.