Ortec Co L T D

FDA Filings

This page includes the latest FDA filings for Ortec Co L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3009119999
• FEI Number: 3009119999
• Name: Priscilla Chung
• Owner & Operator: ORTEC Co., LTD.
• Contact Address: 68 DEOKSANG-RO, SASANG-GU ; Busan KR-NOTA 46939 KR
• Official Correspondent:
  • Byung-wook Ha
  • 82-51-3020895-x
• US Agent:
  • Priscilla Chung
  • LK Consulting Group USA, Inc.
  • 714 2025789
  • juhee.c@lkconsultinggroup.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 1150 ROOSEVELT, SUITE 200 ; Irvine, CA 92620 US
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
NOC Priscilla Chung [ORTEC Co., LTD.]	Palmar Splint	2011-06-07
NOC Priscilla Chung [ORTEC Co., LTD.]	Dynamic Splint	2011-06-07
LGF Priscilla Chung [ORTEC Co., LTD.]	Air Cast	2011-06-07
LGF Priscilla Chung [ORTEC Co., LTD.]	AFO	2011-06-07
ITS Priscilla Chung [ORTEC Co., LTD.]	Hip Abduction	2011-06-07
ITQ Priscilla Chung [ORTEC Co., LTD.]	Soft Knee Brace PCL	2011-06-07
ITQ Priscilla Chung [ORTEC Co., LTD.]	Soft Knee Brace MCL	2011-06-07
ITQ Priscilla Chung [ORTEC Co., LTD.]	Soft Knee Brace ACL	2011-06-07
ITQ Priscilla Chung [ORTEC Co., LTD.]	Knee Immobilizer	2011-06-07
ITQ Priscilla Chung [ORTEC Co., LTD.]	Knee Brace ROM	2011-06-07
ITQ Priscilla Chung [ORTEC Co., LTD.]	Knee Brace OM ROM	2011-06-07
ITQ Priscilla Chung [ORTEC Co., LTD.]	Knee Brace G5 ROM	2011-06-07
ITQ Priscilla Chung [ORTEC Co., LTD.]	Knee Brace G3 ROM	2011-06-07
ITQ Priscilla Chung [ORTEC Co., LTD.]	Knee Brace Cadena ROM	2011-06-07
ITM Priscilla Chung [ORTEC Co., LTD.]	Knee Cage	2011-06-07
IQI Priscilla Chung [ORTEC Co., LTD.]	Thumb Brace	2011-06-07
IQI Priscilla Chung [ORTEC Co., LTD.]	Tennis Elbow	2011-06-07
IQI Priscilla Chung [ORTEC Co., LTD.]	Long arm Brace	2011-06-07
IQE Priscilla Chung [ORTEC Co., LTD.]	VERTALOC TLSO BACK BRACE	2011-06-07
IQE Priscilla Chung [ORTEC Co., LTD.]	V-Corset	2011-06-07
IQE Priscilla Chung [ORTEC Co., LTD.]	Taylor	2011-06-07
IQE Priscilla Chung [ORTEC Co., LTD.]	Taylor 400	2011-06-07
IQE Priscilla Chung [ORTEC Co., LTD.]	Taylor 25	2011-06-07
IQE Priscilla Chung [ORTEC Co., LTD.]	T.L.S.O	2011-06-07
IQE Priscilla Chung [ORTEC Co., LTD.]	OT-Taylor	2011-06-07
IQE Priscilla Chung [ORTEC Co., LTD.]	OT-T.L.S.O	2011-06-07
IQE Priscilla Chung [ORTEC Co., LTD.]	OT-L.S.O	2011-06-07
IQE Priscilla Chung [ORTEC Co., LTD.]	OT-L.S.O (Molding)	2011-06-07
IQE Priscilla Chung [ORTEC Co., LTD.]	OT-Corset	2011-06-07
IQE Priscilla Chung [ORTEC Co., LTD.]	OT-Back Brace	2011-06-07
IQE Priscilla Chung [ORTEC Co., LTD.]	OT- T.L.S.O(New)	2011-06-07
IQE Priscilla Chung [ORTEC Co., LTD.]	Molding Corset	2011-06-07
IQE Priscilla Chung [ORTEC Co., LTD.]	Low Chair Back	2011-06-07
IQE Priscilla Chung [ORTEC Co., LTD.]	Low Back Brace	2011-06-07
IQE Priscilla Chung [ORTEC Co., LTD.]	L.S.O	2011-06-07
IQE Priscilla Chung [ORTEC Co., LTD.]	High Chair Back	2011-06-07
IQE Priscilla Chung [ORTEC Co., LTD.]	High Back Brace	2011-06-07
IQE Priscilla Chung [ORTEC Co., LTD.]	G3 T.L.S.O	2011-06-07
IQE Priscilla Chung [ORTEC Co., LTD.]	G-Corset(Low)	2011-06-07
IQE Priscilla Chung [ORTEC Co., LTD.]	G-Corset(High)	2011-06-07
IQE Priscilla Chung [ORTEC Co., LTD.]	Back Brace	2011-06-07
IQE Priscilla Chung [ORTEC Co., LTD.]	Back Brace 505	2011-06-07
IQE Priscilla Chung [ORTEC Co., LTD.]	Back Brace 501	2011-06-07
IQE Priscilla Chung [ORTEC Co., LTD.]	Back Brace 400	2011-06-07
IQE Priscilla Chung [ORTEC Co., LTD.]	Back Brace 260	2011-06-07
IQE Priscilla Chung [ORTEC Co., LTD.]	Back Brace 210	2011-06-07
IQE Priscilla Chung [ORTEC Co., LTD.]	Back Brace 110	2011-06-07
IQE Priscilla Chung [ORTEC Co., LTD.]	B3 Back brace	2011-06-07
IQE Priscilla Chung [ORTEC Co., LTD.]	B2 Back brace	2011-06-07
IQE Priscilla Chung [ORTEC Co., LTD.]	35 Corset	2011-06-07
IQE Priscilla Chung [ORTEC Co., LTD.]	30 Corset	2011-06-07
IQE Priscilla Chung [ORTEC Co., LTD.]	25 Corset	2011-06-07
ILI Priscilla Chung [ORTEC Co., LTD.]	Ultra-Sling	2011-06-07
ILI Priscilla Chung [ORTEC Co., LTD.]	Shoulder O-Sling	2011-06-07
ILI Priscilla Chung [ORTEC Co., LTD.]	O-Sling	2011-06-07
ILI Priscilla Chung [ORTEC Co., LTD.]	L-Sling	2011-06-07
ILI Priscilla Chung [ORTEC Co., LTD.]	Kenny Howard	2011-06-07
ILI Priscilla Chung [ORTEC Co., LTD.]	Hemi Sling	2011-06-07
ILI Priscilla Chung [ORTEC Co., LTD.]	Bobath Sling	2011-06-07
ILI Priscilla Chung [ORTEC Co., LTD.]	B-Sling	2011-06-07
ILI Priscilla Chung [ORTEC Co., LTD.]	Abduction Pillow	2011-06-07
ILH Priscilla Chung [ORTEC Co., LTD.]	Mallet Finger Splint	2011-06-07
ILH Priscilla Chung [ORTEC Co., LTD.]	Finger Splint	2011-06-07
ILH Priscilla Chung [ORTEC Co., LTD.]	Dynamic splint	2011-06-07

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
201808076693	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	ORTHOSIS PRODUCTS 9021100000	4 CTN
2018080320312	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	ORTHOSIS PRODUCTS 9021100000	4 CTN