Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009119999

FEI Number

3009119999

Entity Name

ORTEC Co., LTD.

City/State/Country

Busan, KR

Establishment Address

68 DEOKSANG-RO, SASANG-GU, Busan 46939, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ORTEC Co., LTD. (Owner Number: 10036960)

Owner / Operator Contact Address

68 DEOKSANG-RO, SASANG-GU, Busan, KR-NOTA 46939, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Long arm Brace Tennis Elbow Thumb Brace Bobath Sling Abduction Pillow L-Sling Kenny Howard Ultra-Sling Hemi Sling B-Sling O-Sling Shoulder O-Sling Hip Abduction Dynamic splint Finger Splint Mallet Finger Splint AFO Air Cast Knee Immobilizer Soft Knee Brace PCL Knee Brace G3 ROM Soft Knee Brace MCL Knee Brace G5 ROM Knee Brace ROM Knee Brace Cadena ROM Soft Knee Brace ACL Knee Brace OM ROM T.L.S.O Taylor 25 Molding Corset Back Brace VERTALOC TLSO BACK BRACE L.S.O 35 Corset OT-T.L.S.O G-Corset(Low) Back Brace 501 Low Back Brace Taylor 400 V-Corset 25 Corset High Back Brace OT-Taylor OT-Corset Back Brace 210 Back Brace 505 Back Brace 400 OT- T.L.S.O(New) B2 Back brace Back Brace 260 Back Brace 110 OT-L.S.O (Molding) G3 T.L.S.O Halo Vest G-Corset(High) OT-L.S.O 30 Corset B3 Back brace Taylor OT-Back Brace High Chair Back Low Chair Back Knee Cage

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2011-06-07
ILI	Sling, Arm	Physical Medicine	Class 1	890.3640	2011-06-07
ITS	Joint, Hip, External Brace	Physical Medicine	Class 1	890.3475	2011-06-07
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2011-06-07
LGF	Component, Cast	Orthopedic	Class 1	888.5940	2011-06-07
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2011-06-07
IQE	Orthosis, Lumbar	Physical Medicine	Class 1	890.3490	2011-06-07
ITM	Cage, Knee	Physical Medicine	Class 1	890.3475	2011-06-07

Official Correspondent

Byung-wook Ha

US Agent Details

Priscilla Chung Business: LK Consulting Group USA, Inc. Email: juhee.c@lkconsultinggroup.com Phone: (714) 2025789

Related Public Records

Same Entity

ORTEC Co., LTD.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009119999. Last updated year: 2026. Please use registration number 3009119999 when referencing this establishment in official correspondence.