FDA Registration
Active
🇭🇺 Hungary
L Z FORM KFT
Reg #: 3008215723
·
FEI: 3008215723
·
Expires 2026
Products
8
Proprietary Names
28
Establishment Types
1
Classifications
8
Registration Details
- Registration Name
- L Z FORM KFT
- Registration Number
- 3008215723
- FEI Number
- 3008215723
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Ipari Park Nyugat hrsz. 5704/4
- City
- Ajka Veszprem
- Country
- HU
Owner / Operator
- Firm Name
- L Z Form Kft
- Operator Number
- 10043808
- Address
- Ipari Park Nyugat hrsz. 5704/4
- City
- Ajka
- State
- Veszprem
- Postal Code
- 8400
- Country
- HU
- Correspondent
- Jozsef Polyik
US Agent
- Business Name
- Pragmatic Compliance dba FDAbasics
- Contact Name
- Jerry Doane
- Address
- 15815 SW 11th Court Rd
- City
- Ocala
- State
- FL
- ZIP
- 34473
- Country
- US
- [email protected]
- Phone
- 716 7750533
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Cement, Bone, Vertebroplasty | NDN | Class 2 | Orthopedic | No | 2017-04-21 |
| Dispenser, Cement | KIH | Class 1 | Orthopedic | No | 2017-04-21 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2020-08-12 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2015-09-10 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2015-09-10 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2017-04-21 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2015-09-10 |
| Injector, Vertebroplasty (Does Not Contain Cement) | OAR | Class 1 | Orthopedic | No | 2015-09-10 |
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
Master Syringe Assembly
Hydraulic Assembly
Hydraulic-Master Syringe Assembly
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)