Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006172536

FEI Number

3006172536

Entity Name

Wenzel Spine

City/State/Country

Austin, TX, US

Establishment Address

2535 Brockton Dr Ste 450, Austin, TX 78758, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Wenzel Spine, Inc. (Owner Number: 10030760)

Owner / Operator Contact Address

2535 Brockton Dr, Suite 450, Austin, TX 78758, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K250247

PMA Number

N/A

All Registered Proprietary Names

PrimaLOK-FF Facet Fixation System PrimaLOK-SP Interspinous Fusion System VMA 3 VariLift-C Interbody Fusion System VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion System PrimaLOK-SP Interspinous Fusion System VariLift-A Interbody Fusion System panaSIa SI Fusion System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MRW	System, Facet Screw Spinal Device	Unknown	Class U	N/A	2017-01-09
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2017-01-09
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2021-06-22
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2025-12-31
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2020-11-16
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2020-11-16
PEK	Spinous Process Plate	Orthopedic	Class 2	888.3050	2025-08-05
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2010-09-21
OUR	Sacroiliac Joint Fixation	Orthopedic	Class 2	888.3040	2025-07-16

Official Correspondent

Erik Emstad

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Wenzel Spine, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K173198	U&I Corporation	Facet Screw Fixation System	2018-01-03
K121850	Choicespine, LP	Typhoon(TM) Facet Screw Fixation System	2012-09-20
K963639	Acromed Corp.	ACROMED PEDICLE SCREW	1996-11-14
K080013	Agfa Healthcare Corporation	REGISTRATION AND FUSION	2008-01-17
K042221	Barco NV Barcoview	CORONIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM	2004-12-30

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-2012	Osteomed, Lp 3885 Arapaho Rd Addison TX 75001	U	OSTEOMED SPINE Facet Fixation System PrimaLOK FF Threaded Implant Driver Shaft OsteoMed L.P. 3885 Arapaho Road, Addison, Texas 75001
Z-0026-2011	Zimmer Inc.	2	SpeedLink 5.5 Transverse Connector Short 39.5-44mm, non-sterile, 1302-55S
Z-0027-2011	Zimmer Inc.	2	SpeedLink 5.5 Transverse Connector Medium 43-51mm, non-sterile, 1302-55M
Z-0028-2011	Zimmer Inc.	2	SpeedLink 5.5 Transverse Connector Long 50-65mm, non-sterile, 1302-55L
Z-0029-2011	Zimmer Inc.	2	SpeedLink 5.5 Transverse Connector X-Long 60-75mm, non-sterile, 1302-55XL

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006172536. Last updated year: 2026. Please use registration number 3006172536 when referencing this establishment in official correspondence.