Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014747863

FEI Number

3014747863

Entity Name

AB ORTOPEDIJOS TECHNIKA

City/State/Country

Kaunas Kauno Apskritis, LT

Establishment Address

Partizanu g. 17, Kaunas Kauno Apskritis LT-49476, LT

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

AB Ortopedijos technika (Owner Number: 10075966)

Owner / Operator Contact Address

Partizanu g. 17, Kaunas, LT-KU LT-49476, LT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KIJ	Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2024-12-18
IPG	Shoe, Cast	Physical Medicine	Class 1	890.3025	2024-12-18
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2024-12-18
KYS	Insoles, Medical	General Hospital	Class 1	880.6280	2024-12-18
OHI	Orthosis, Foot Drop	Physical Medicine	Class 1	890.3475	2021-12-14
NDA	Helmet, Cranial, For Protective Use	Physical Medicine	Class 1	890.3025	2024-12-18
ISH	Component, External, Limb, Ankle/Foot	Physical Medicine	Class 1	890.3420	2020-07-02
IPM	Cover, Limb	Physical Medicine	Class 1	890.3025	2021-01-21

Official Correspondent

Vilma Bendziuviene

US Agent Details

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

Related Public Records

Same Entity

AB Ortopedijos technika

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
K933337	R & D Batteries, Inc.	R AND D BATTERY REPLACEMENT	1994-04-05
K873766	Bowen & Company, Inc.	STERNAL POWER AWL	1988-11-14

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1834331	PARAGON MEDICAL, INC.	PIERCETON, IN, US
3006460162	ORTHOPEDIATRICS, CORP	Warsaw, IN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014747863. Last updated year: 2026. Please use registration number 3014747863 when referencing this establishment in official correspondence.