Optec Usa Inc

FDA Filings

This page includes the latest FDA filings for Optec Usa Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Optec Usa Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

• MEDEX MEDICAL SUPPLIES LTD.
• OPTEC USA, INC

FDA Registration(s)

• Registration Number: 3011528799
• FEI Number: 3011528799
• Name: OPTEC USA, INC
• Owner & Operator: OPTEC USA, INC.
• Contact Address: 975 PROGRESS CIRCLE --; Lawrenceville GA 30043 US
• Official Correspondent:
  • Daniel - Suarez
  • x-770-5137380-x
• US Agent:
  • Daniel - Suarez
  • OPTEC USA, INC.
  • 770 5137380
  • OPTECCORP@AOL.COM
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: SOLAR 3, MANZANA 2-B ZONA FRANCA INDUSTRIAL SAN PEDRO DE MACORIS; SAN PEDRO DE MACORIS San Pedro de Macori, XXXX DO
• Establishment Type: Repack or Relabel Medical Device

• Registration Number: 1063727
• FEI Number: 3001779564
• Name: OPTEC USA, INC.
• Owner & Operator: OPTEC USA, INC.
• Contact Address: 975 PROGRESS CIRCLE --; Lawrenceville GA 30043 US
• Official Correspondent:
  • Daniel - Suarez
  • x-770-5137380-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 975 PROGRESS CIRCLE ; LAWRENCEVILLE, GA 30043 US
• Establishment Type:
  • Repack or Relabel Medical Device
  • Manufacture Medical Device

FDA Filings

Device Company	Device	Date
MRI OPTEC USA, INC.	Optec Orthosis, Truncal/Orthosis, Limb	2012-11-26
MRI OPTEC USA, INC [OPTEC USA, INC.]	Optec Orthosis, Truncal/Orthosis, Limb	2012-11-26
KTD OPTEC USA, INC.	Optec Orthosis, Abdominal	2012-11-26
KTD OPTEC USA, INC [OPTEC USA, INC.]	Optec Orthosis, Abdominal	2012-11-26
ITW OPTEC USA, INC.	Optec Joint, Ankle, External Brace	2012-11-26
ITQ OPTEC USA, INC.	Optec Joint, Knee, External Brace	2012-11-26
ITC OPTEC USA, INC.	Optec Stirrup, External Brace Component	2012-11-26
ISY OPTEC USA, INC.	Optec Joint, Knee, External Limb Component	2012-11-26
ISH OPTEC USA, INC.	Roadrunnerfoot	2012-11-26
IRD OPTEC USA, INC.	Optec Joint, Elborw, External Limb Component, Mechanical	2012-11-26
IQQ OPTEC USA, INC.	Optec Joint, Shoulder, External Limb Component	2012-11-26
IQQ OPTEC USA, INC [OPTEC USA, INC.]	Optec Joint, Shoulder, External Limb Component	2012-11-26
IQK OPTEC USA, INC.	Optec Orthosis, Cervical	2012-11-26
IQK OPTEC USA, INC [OPTEC USA, INC.]	Optec Orthosis, Cervical	2012-11-26
IQI OPTEC USA, INC.	Optec Orthosis, Limb Brace	2012-11-26
IQI OPTEC USA, INC [OPTEC USA, INC.]	Optec Orthosis, Limb Brace	2012-11-26
IQE OPTEC USA, INC.	Optec Orthosis, Lumbar	2012-11-26
IQE OPTEC USA, INC [OPTEC USA, INC.]	Optec Orthosis, Lumbar	2012-11-26
ILI OPTEC USA, INC.	Optec Sling, Arm	2012-11-26
ILH OPTEC USA, INC.	Optec Splint, Hand, and Components	2012-11-26
ITS OPTEC USA, INC.	TLC	2007-11-19
ITS OPTEC USA, INC.	TLC2	2007-11-19
ITS OPTEC USA, INC.	EDGE THIGH CUFF	2007-11-19
ITS OPTEC USA, INC.	EDGE HIP JOINT	2007-11-19
ITS OPTEC USA, INC [OPTEC USA, INC.]	TLC	2007-11-19
ITS OPTEC USA, INC [OPTEC USA, INC.]	TLC2	2007-11-19
ITS OPTEC USA, INC [OPTEC USA, INC.]	EDGE THIGH CUFF	2007-11-19
ITS OPTEC USA, INC [OPTEC USA, INC.]	EDGE HIP JOINT	2007-11-19
IQF OPTEC USA, INC.	STOCK	2007-11-19
IQF OPTEC USA, INC.	STOCK MINERVA ATTACHMENT	2007-11-19
IQF OPTEC USA, INC.	CHELSEA CTO	2007-11-19
IQF OPTEC USA, INC [OPTEC USA, INC.]	STOCK	2007-11-19
IQF OPTEC USA, INC [OPTEC USA, INC.]	STOCK MINERVA ATTACHMENT	2007-11-19
IQF OPTEC USA, INC [OPTEC USA, INC.]	CHELSEA CTO	2007-11-19
IPT OPTEC USA, INC.	Stealth	2007-11-19
IPT OPTEC USA, INC.	Salo	2007-11-19
IPT OPTEC USA, INC.	STOCK	2007-11-19
IPT OPTEC USA, INC.	STOCK STERNAL PAD KIT	2007-11-19
IPT OPTEC USA, INC.	STOCK MINERVA ATTACHMENT	2007-11-19
IPT OPTEC USA, INC.	Primo	2007-11-19
IPT OPTEC USA, INC.	Oasis	2007-11-19
IPT OPTEC USA, INC.	Lumbitec	2007-11-19
IPT OPTEC USA, INC.	Evotec	2007-11-19
IPT OPTEC USA, INC.	Edge	2007-11-19
IPT OPTEC USA, INC [OPTEC USA, INC.]	Stealth	2007-11-19
IPT OPTEC USA, INC [OPTEC USA, INC.]	Salo	2007-11-19
IPT OPTEC USA, INC [OPTEC USA, INC.]	STOCK	2007-11-19
IPT OPTEC USA, INC [OPTEC USA, INC.]	STOCK STERNAL PAD KIT	2007-11-19
IPT OPTEC USA, INC [OPTEC USA, INC.]	STOCK MINERVA ATTACHMENT	2007-11-19
IPT OPTEC USA, INC [OPTEC USA, INC.]	Primo	2007-11-19
IPT OPTEC USA, INC [OPTEC USA, INC.]	Oasis	2007-11-19
IPT OPTEC USA, INC [OPTEC USA, INC.]	Lumbitec	2007-11-19
IPT OPTEC USA, INC [OPTEC USA, INC.]	Evotec	2007-11-19
IPT OPTEC USA, INC [OPTEC USA, INC.]	Edge	2007-11-19
IPY OPTEC USA, INC.	VERTABRACE	2004-02-11
IPY OPTEC USA, INC.	STOCK	2004-02-11
IPY OPTEC USA, INC.	STOCK STERNAL PAD KIT	2004-02-11
IPY OPTEC USA, INC.	STOCK MINERVA ATTACHMENT	2004-02-11
IPY OPTEC USA, INC.	STEALTH	2004-02-11
IPY OPTEC USA, INC.	SALO	2004-02-11
IPY OPTEC USA, INC.	PRIMO	2004-02-11
IPY OPTEC USA, INC.	OPTEC OASIS SOFT SPI	2004-02-11
IPY OPTEC USA, INC.	OASIS	2004-02-11
IPY OPTEC USA, INC.	LUMBITEC	2004-02-11
IPY OPTEC USA, INC.	EVOTEC	2004-02-11
IPY OPTEC USA, INC.	EDGE	2004-02-11
IPY OPTEC USA, INC [OPTEC USA, INC.]	VERTABRACE	2004-02-11
IPY OPTEC USA, INC [OPTEC USA, INC.]	STOCK	2004-02-11
IPY OPTEC USA, INC [OPTEC USA, INC.]	STOCK STERNAL PAD KIT	2004-02-11
IPY OPTEC USA, INC [OPTEC USA, INC.]	STOCK MINERVA ATTACHMENT	2004-02-11
IPY OPTEC USA, INC [OPTEC USA, INC.]	STEALTH	2004-02-11
IPY OPTEC USA, INC [OPTEC USA, INC.]	SALO	2004-02-11
IPY OPTEC USA, INC [OPTEC USA, INC.]	PRIMO	2004-02-11
IPY OPTEC USA, INC [OPTEC USA, INC.]	OPTEC OASIS SOFT SPI	2004-02-11
IPY OPTEC USA, INC [OPTEC USA, INC.]	OASIS	2004-02-11
IPY OPTEC USA, INC [OPTEC USA, INC.]	LUMBITEC	2004-02-11
IPY OPTEC USA, INC [OPTEC USA, INC.]	EVOTEC	2004-02-11
IPY OPTEC USA, INC [OPTEC USA, INC.]	EDGE	2004-02-11

Related Finance Registrations

NCAGE Code	43JV3	OPTEC USA, INC
CAGE Code	43JV3	OPTEC USA, INC
S.A.M. Registration	43JV3 [188430920]	OPTEC USA, INC
S.A.M. Registration	43JV3 [188430920]	OPTEC USA, INC

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020072049307	Rio Jaina,Dominican Republic -> Port Everglades, Florida	ORTHOPEDIC PRODUCTS SLAC 104 BOXES OF ORTHOPEDIC PRODUCTS NONE	104 BOX
202005115416	Pusan,South Korea -> Savannah, Georgia	IRON FENCE FENCE GATE	391 PKG
2020032442800	Stadersand,Federal Republic of Germany -> Savannah, Georgia	INDUSTRIAL ROBOTS (IN USED CONDITION) ROBOT KUKA KR210/L150-2 2000 ED05 KR210/L180-2 2000 ED05 TOTAL 2 UNITS	1 PCS
2020021749011	Rio Jaina,Dominican Republic -> Miami, Florida	MEDICAL ORTHOPEDIC PRODUCTS	163 CTN
2019123125182	Genova,Italy -> New York/Newark Area, Newark, New Jersey	MEDICAL PRODUCTS	1 PKG
2019123162266	Rio Jaina,Dominican Republic -> Miami, Florida	MEDICAL ORTHOPEDIC PRODUCTS	323 CTN
2019080676119	Rio Jaina,Dominican Republic -> Miami, Florida	MEDICAL ORTHOPEDIC PRODUCTS	450 CTN
2019061151736	Rio Jaina,Dominican Republic -> Miami, Florida	MEDICAL ORTHOPEDIC PRODUCTS	238 CTN