FDA Registration
Active
🇱🇹 Lithuania
AB ORTOPEDIJOS TECHNIKA
Reg #: 3014747863
·
FEI: 3014747863
·
Expires 2026
Products
8
Proprietary Names
30
Establishment Types
2
Classifications
8
Registration Details
- Registration Name
- AB ORTOPEDIJOS TECHNIKA
- Registration Number
- 3014747863
- FEI Number
- 3014747863
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Partizanu g. 17
- City
- Kaunas Kauno Apskritis
- Country
- LT
Owner / Operator
- Firm Name
- AB Ortopedijos technika
- Operator Number
- 10075966
- Address
- Partizanu g. 17
- City
- Kaunas
- State
- Kauno Apskritis
- Postal Code
- LT-49476
- Country
- LT
- Correspondent
- Vilma Bendziuviene
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 |
|---|---|---|---|---|---|
| Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment | KIJ | Class 1 | General, Plastic Surgery | No | 2024-12-18 |
| Shoe, Cast | IPG | Class 1 | Physical Medicine | No | 2024-12-18 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2024-12-18 |
| Insoles, Medical | KYS | Class 1 | General Hospital | No | 2024-12-18 |
| Orthosis, Foot Drop | OHI | Class 1 | Physical Medicine | No | 2021-12-14 |
| Helmet, Cranial, For Protective Use | NDA | Class 1 | Physical Medicine | No | 2024-12-18 |
| Component, External, Limb, Ankle/Foot | ISH | Class 1 | Physical Medicine | No | 2020-07-02 |
| Cover, Limb | IPM | Class 1 | Physical Medicine | No | 2021-01-21 |
Proprietary Names
Uppers for orthopaedic footwear
Standard post-operative boot
Complete orthopaedic footwear with or without various orthopaedic elements
Footwear lasts custom made
Footwear lasts standard
Standard orthopaedic footwear
Test plastic shoes
shoulder-elbow orthoses
other orthoses
thoraco-lumbo-sacral orthoses
ankle-foot orthoses
shoulder orthoses
maternity orthoses
knee orthoses
Standard and custom made
Custom made orthosis DAFO, AFO, KAFO, KO with or without joints, insoles, Chopart insoles, soft parts and other
finger/wrist/hand orthoses
cervical orthoses
lumbo-sacral/lumbar orthoses
Standard orthopaedic footwear insoles
Custom made Chopart insoles
Custom-made various products for forefoot amputation (Chopar and others): insoles, insoles with orthosis
Standard various products for forefoot amputation (Chopar and others): insoles, insoles with orthosis
orthopaedic footwear insoles
medical, with or without various orthopaedic elements such as fixation insoles
M2 AFO
protective face mask and other similar products for protection (Standard and custom made)
Protective head helmet
Protector Sleeve
Volume Compensation Socks
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)