Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008215723

FEI Number

3008215723

Entity Name

L Z FORM KFT

City/State/Country

Ajka Veszprem, HU

Establishment Address

Ipari Park Nyugat hrsz. 5704/4, Ajka Veszprem 8400, HU

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

L Z Form Kft (Owner Number: 10043808)

Owner / Operator Contact Address

Ipari Park Nyugat hrsz. 5704/4, Ajka, HU-VE 8400, HU

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

First Fracture Kit PowerCurve Blister Tray Assembly for StabiliT MX with PowerCURVE Activation Element Arcadia Balloon Catheter Locking Delivery Cannula 3 StabiliT Delivery Instruments Long StabiliT Introducer 3.6-B StabiliT Introducer 3.6-11.5-ED Locking Delivery Cannula 3-11.5-ED StabiliT Introducer 3.6-D StabilT Delivery Instruments Short StabiliT Introducer 3.6-11.5-EB VertecoR Bone Drill Sub Assembly.Vertebral.Blister Tray Assembly for MX.(Full,Long) Non Sterile Blister Tray Assembly for STAR with PowerCURVE AE Cable SpineSTAR Ablation Instrument 10 15 [Long] SpineSTAR Ablation Instrument (10 15) Hand Switch Cable SpineSTAR Ablation Instrument 5 10 [Long] SpineSTAR Ablation Instrument 5 10 PowerCURVE Navigating Osteotome, Short VertecoR StraightLine Cement Staging Osteotome Long PowerCURVE Navigating Osteotome, Long VertecoR StraightLine Cement Staging Osteotome Short

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NDN	Cement, Bone, Vertebroplasty	Orthopedic	Class 2	888.3027	2017-04-21
KIH	Dispenser, Cement	Orthopedic	Class 1	888.4200	2017-04-21
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2020-08-12
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2015-09-10
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2015-09-10
NDN	Cement, Bone, Vertebroplasty	Orthopedic	Class 2	888.3027	2018-11-09
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2017-04-21
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2015-09-10

Official Correspondent

Jozsef Polyik

US Agent Details

Jerry Doane Business: Pragmatic Compliance dba FDAbasics Email: usagent@fdabasics.com Phone: (716) 7750533

Related Public Records

Same Entity

L Z Form Kft

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
K081051	Spine View, Inc.	SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS), SPINEVU MINISCOPE	2008-08-07
K820777	The Anspach Effort, Inc.	MINI-MICRO ARTHROSCOPIC SCAPEL	1982-05-12
K970809	Somnus Medical Technologies, Inc.	BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL	1997-06-18
K222793	C.R. Bard, Inc.	WavelinQ Generator	2022-10-17
K002257	Tecno Instruments (Pvt.) , Ltd.	TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100	2000-10-19

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0041-05	Linvatec Corp.	2	Ultra Power Burs, Sterile, Single-Use.
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826
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
Z-0011-06	Stryker Howmedica Osteonics Corp.	1	Allocraft TLIF Bone Inserter.

Similar Registrations

Registration Number	Establishment Name	Location
3044858680	JIENO YOUCHENG MEDICAL TECHNOLOGY (SHANGHAI) CO., LTD.	Shanghai, CN
3014725904	Medtronic Medical Costa Rica S.R.L.	Coyol Alajuela, CR
2648623	STERIS ISOMEDIX PUERTO RICO, INC.	Alts De Cerro Gordo 3&4, PR, US
3015309643	Merit Medical UK Limited	Earley Reading, GB
3008572623	ELMDOWN SRL UNIPERSONALE	milano Lombardy, IT

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008215723. Last updated year: 2026. Please use registration number 3008215723 when referencing this establishment in official correspondence.