Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007344102

FEI Number

3007344102

Entity Name

VORZEIGEN

City/State/Country

Connersville, IN, US

Establishment Address

5650 Industrial Ave S, Connersville, IN 47331, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Vorzeigen (Owner Number: 10046317)

Owner / Operator Contact Address

5650 Industrial Ave South, Connersville, IN 47331, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

4mm Nav Guide Window Tap LENKE PROBE, STRAIGHT, NAVIGATION Rod, Fixation, Intramedullary 6mm Solid Tap, Double Lead, 140mm 5mm Tap, 25mm Length, Hudson 4mm Tap, 25mm Length, Hudson Canal Sizer Stylet - Luer Lock Cannulated Tap BandLoc Mini Lrg Set Screw Caddy Lid BandLoc Mini Lrg Set Screw Caddy BandLoc Mini Lid BandLoc Mini Base Assembly VITEK 2 GN AST for Cefcapene HOOK STAGING TRAY 3.5mm Hudson Tap 4.5mm Hudson Tap - Single Lead 3.5mm Hudson Tap - Single Lead 5.5mm Hudson Tap 3mm Hudson Tap - Single Lead 7mm Hudson Tap - Single Lead 4.5mm Hudson Tap 5mm Hudson Tap - Single Lead 6mm Hudson Tap - Single Lead 5.5mm Hudson Tap - Single Lead 4mm Hudson Tap - Single Lead 8mm Hudson Tap - Single Lead

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2024-06-18
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2024-11-04
KIJ	Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2024-06-18
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2014-11-18
HWX	Tap, Bone	Orthopedic	Class 1	888.4540	2023-04-03
HWR	Driver, Prosthesis	Orthopedic	Class 1	888.4540	2014-03-05
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2014-11-18
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	2024-09-10
GAH	Stylet, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2024-06-18
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2019-01-29
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2008-04-30
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2019-09-20
GFG	Bit, Surgical	General, Plastic Surgery	Class 1	878.4820	2024-03-05

Official Correspondent

Austin Cummings

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Vorzeigen

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
K260601	Blue Belt Technologies, Inc.	REAL INTELLIGENCE CORI	2026-03-26
K040336	Synthes (Usa)	SYNTHES (USA) LATERAL ENTRY FEMORAL NAIL SYSTEM	2004-04-12
K083648	Efratgo, Ltd. HI Tech Bio-Surgical	GOTFRIED PHYSIOLOGICAL HIP (PH) NAIL	2009-05-14
K192312	Zimmer GmbH	Zimmer Natural Nail System Cephalomedullary Nails	2019-10-11
K002057	Biomet Orthopedics, Inc.	BROOKER TIBIA NAILS	2000-10-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0041-2024	Blue Belt Technologies, Inc	2	Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299
Z-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.
Z-0170-2015	Siemens Healthcare Diagnostics, Inc.	2	Rapid Neg BP Combo Panel Type 3; Catalog number B 1017-117. MicroScan Rapid panels are designed for use in determining identification to the species level and/or antimicrobial agent susceptibility of rapidly growing aerobic and facultatively anaerobic gram negative bacilli.
Z-0009-2007	Smith & Nephew Inc	1	Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.
Z-0010-2007	Smith & Nephew Inc	1	Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007344102. Last updated year: 2026. Please use registration number 3007344102 when referencing this establishment in official correspondence.