First Gold Corp

FDA Filings

This page includes the latest FDA filings for First Gold Corp. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

First Gold Corp holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

• SangChul Ha

FDA Registration(s)

• Registration Number: 3010509633
• FEI Number: 3010509633
• Name: FIRST GOLD CORP.
• Owner & Operator: FIRST GOLD CORP.
• Contact Address: 5072 W PLANO PKWY STE 210 ; Plano TX 75093 US
• Official Correspondent:
  • MIN SEOK SEO
  • 1-469-3058207-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 5072 W PLANO PKWY STE 210 ; Plano, TX 75093 US
• Establishment Type: Repack or Relabel Medical Device

FDA Filings

Device Company	Device	Date
PMN K190471 | NKB FIRST GOLD CORP.	4CIS? Chiron Spinal Fixation System	2019-07-31
PMN K181190 | KWQ FIRST GOLD CORP.	4CIS Pinehurst Anterior Cervical Plate System	2019-03-25
PMN K162402 | ODP FIRST GOLD CORP.	4CIS Marlin Anterior Cervical Interbody Fusion Cage system	2019-03-25
PMN K151468 | HWC FIRST GOLD CORP.	ARIX Wrist System	2016-09-12
PMN K151468 | HRS FIRST GOLD CORP.	ARIX Wrist System	2016-09-12
PMN K131566 | HRS FIRST GOLD CORP.	ARIX Hand System	2016-09-12
LXH FIRST GOLD CORP.	VP Needle Diamond type	2016-09-12
LXH FIRST GOLD CORP.	VANE Screw Tray	2016-09-12
LXH FIRST GOLD CORP.	VANE Poly Axial Screw Driver	2016-09-12
LXH FIRST GOLD CORP.	VANE Instruments Container	2016-09-12
LXH FIRST GOLD CORP.	VANE Implants Container	2016-09-12
LXH FIRST GOLD CORP.	VANE Accessory Case	2016-09-12
LXH FIRST GOLD CORP.	VANE 5.7 Poly Axial Screw Driver small	2016-09-12
LXH FIRST GOLD CORP.	VANE 5.7 Poly Axial Screw Driver Small Cannula	2016-09-12
LXH FIRST GOLD CORP.	Torque Wrench	2016-09-12
LXH FIRST GOLD CORP.	Torque Limiter for 12Nm	2016-09-12
LXH FIRST GOLD CORP.	Torque Limit Handle	2016-09-12
LXH FIRST GOLD CORP.	Tester	2016-09-12
LXH FIRST GOLD CORP.	Tester, Straight	2016-09-12
LXH FIRST GOLD CORP.	Tester, Curved	2016-09-12
LXH FIRST GOLD CORP.	Tap	2016-09-12
LXH FIRST GOLD CORP.	Tap 7.5	2016-09-12
LXH FIRST GOLD CORP.	Tap 6.5	2016-09-12
LXH FIRST GOLD CORP.	Tap 5.5	2016-09-12
LXH FIRST GOLD CORP.	TORQUE STABILIZER	2016-09-12
LXH FIRST GOLD CORP.	TAB BREAKER	2016-09-12
LXH FIRST GOLD CORP.	T-handle Large Square Rachet Left type	2016-09-12
LXH FIRST GOLD CORP.	T-Handle	2016-09-12
LXH FIRST GOLD CORP.	Straight Rod Caddy	2016-09-12
LXH FIRST GOLD CORP.	Square T-handle	2016-09-12
LXH FIRST GOLD CORP.	Slap Hammer	2016-09-12
LXH FIRST GOLD CORP.	Slap Hammer Adaptor	2016-09-12
LXH FIRST GOLD CORP.	Screw Driver 3HEX	2016-09-12
LXH FIRST GOLD CORP.	Screw Case	2016-09-12
LXH FIRST GOLD CORP.	Screw Aligner	2016-09-12
LXH FIRST GOLD CORP.	SCREW DRIVER	2016-09-12
LXH FIRST GOLD CORP.	Rod Rocker	2016-09-12
LXH FIRST GOLD CORP.	Rod Rocker Forceps type	2016-09-12
LXH FIRST GOLD CORP.	Rod Pusher	2016-09-12
LXH FIRST GOLD CORP.	Rod Length Gauge	2016-09-12
LXH FIRST GOLD CORP.	Rod Introducer	2016-09-12
LXH FIRST GOLD CORP.	Rod Holder	2016-09-12
LXH FIRST GOLD CORP.	Rod Gripper	2016-09-12
LXH FIRST GOLD CORP.	Rod Caddy	2016-09-12
LXH FIRST GOLD CORP.	Ring	2016-09-12
LXH FIRST GOLD CORP.	Reamer Sharp	2016-09-12
LXH FIRST GOLD CORP.	Reamer Sharp 4degree	2016-09-12
LXH FIRST GOLD CORP.	Reamer Blunt	2016-09-12
LXH FIRST GOLD CORP.	Ratchet T-Handle	2016-09-12
LXH FIRST GOLD CORP.	Ratchet I-Handle	2016-09-12
LXH FIRST GOLD CORP.	ROD REDUCER	2016-09-12
LXH FIRST GOLD CORP.	ROD GAUGE	2016-09-12
LXH FIRST GOLD CORP.	RIGID ROD INSERTER	2016-09-12
LXH FIRST GOLD CORP.	Probe for 6.5mm Screw, Straight	2016-09-12
LXH FIRST GOLD CORP.	Probe for 6.5mm Screw, Curved	2016-09-12
LXH FIRST GOLD CORP.	Probe for 5.5mm Screw, Straight	2016-09-12
LXH FIRST GOLD CORP.	Poly-Axial Bone Screw Final Driver	2016-09-12
LXH FIRST GOLD CORP.	Poly Axial Screw Final Drvier	2016-09-12
LXH FIRST GOLD CORP.	Poly Axial Screw Driver	2016-09-12
LXH FIRST GOLD CORP.	Poly Axial Screw Aligner	2016-09-12
LXH FIRST GOLD CORP.	Poly Axial Bone Screw Final Driver, Short	2016-09-12
LXH FIRST GOLD CORP.	Persuader	2016-09-12
LXH FIRST GOLD CORP.	Persuader, Short	2016-09-12
LXH FIRST GOLD CORP.	Pedicle Probe for 6.5 Screw	2016-09-12
LXH FIRST GOLD CORP.	Pedicle Probe for 5.5 Screw	2016-09-12
LXH FIRST GOLD CORP.	PLIF Last Impactor	2016-09-12
LXH FIRST GOLD CORP.	PEEK PLIF Cage Trial	2016-09-12
LXH FIRST GOLD CORP.	PEEK PLIF Cage Implants Case	2016-09-12
LXH FIRST GOLD CORP.	PEEK PLIF Cage Holder	2016-09-12
LXH FIRST GOLD CORP.	PEEK PLIF Cage Graphic Container	2016-09-12
LXH FIRST GOLD CORP.	PEEK Cage Holder	2016-09-12
LXH FIRST GOLD CORP.	OBTURATOR	2016-09-12
LXH FIRST GOLD CORP.	Nut Starter	2016-09-12
LXH FIRST GOLD CORP.	Nut Starter, Short	2016-09-12
LXH FIRST GOLD CORP.	Nut Starter Final Hub	2016-09-12
LXH FIRST GOLD CORP.	Nut Screw Inserter	2016-09-12
LXH FIRST GOLD CORP.	Nut Screw Guide	2016-09-12
LXH FIRST GOLD CORP.	Nut Inserter	2016-09-12
LXH FIRST GOLD CORP.	Nut Guide	2016-09-12
LXH FIRST GOLD CORP.	Nut Final Wrench	2016-09-12
LXH FIRST GOLD CORP.	Nut Final Driver	2016-09-12
LXH FIRST GOLD CORP.	Nut Final Driver, Short	2016-09-12
LXH FIRST GOLD CORP.	NUT SCREW FINAL DRIVER	2016-09-12
LXH FIRST GOLD CORP.	Mono Axial Screw Driver	2016-09-12
LXH FIRST GOLD CORP.	Mono Axial Screw Driver, Short	2016-09-12
LXH FIRST GOLD CORP.	Mono Axial & Reduction Screw Driver	2016-09-12
LXH FIRST GOLD CORP.	MEDINAUT-lx(various models)	2016-09-12
LXH FIRST GOLD CORP.	Lordotic Cage Caddy	2016-09-12
LXH FIRST GOLD CORP.	LONG PLIF CAGE Caddy	2016-09-12
LXH FIRST GOLD CORP.	Instrument Container	2016-09-12
LXH FIRST GOLD CORP.	Instrument Case	2016-09-12
LXH FIRST GOLD CORP.	Initial Driver	2016-09-12
LXH FIRST GOLD CORP.	Initial Driver Square Type	2016-09-12
LXH FIRST GOLD CORP.	In-line Handle Square Rachet	2016-09-12
LXH FIRST GOLD CORP.	Implant Container	2016-09-12
LXH FIRST GOLD CORP.	Implant Case	2016-09-12
LXH FIRST GOLD CORP.	HEAD ALIGNER	2016-09-12
LXH FIRST GOLD CORP.	Guide Wire	2016-09-12
LXH FIRST GOLD CORP.	Guide Wire Diamond Tip	2016-09-12
LXH FIRST GOLD CORP.	Guide Pins Triangle	2016-09-12
LXH FIRST GOLD CORP.	Guide Pins Ellipse	2016-09-12
LXH FIRST GOLD CORP.	Graft Impactor	2016-09-12
LXH FIRST GOLD CORP.	Graft Holder	2016-09-12
LXH FIRST GOLD CORP.	GUIDE WIRE TOOL	2016-09-12
LXH FIRST GOLD CORP.	French Rod Bender	2016-09-12
LXH FIRST GOLD CORP.	Fixing Sleeve Opened-type	2016-09-12
LXH FIRST GOLD CORP.	Fixing Sleeve Closed Long-type	2016-09-12
LXH FIRST GOLD CORP.	FIXING SLEEVE	2016-09-12
LXH FIRST GOLD CORP.	EMG Sleeve	2016-09-12
LXH FIRST GOLD CORP.	Durameter Retractor	2016-09-12
LXH FIRST GOLD CORP.	Distractor	2016-09-12
LXH FIRST GOLD CORP.	DISSECTOR	2016-09-12
LXH FIRST GOLD CORP.	DILATOR3	2016-09-12
LXH FIRST GOLD CORP.	DILATOR2	2016-09-12
LXH FIRST GOLD CORP.	DILATOR1	2016-09-12
LXH FIRST GOLD CORP.	Cross-link Driver Shaft(HEX 3.0)	2016-09-12
LXH FIRST GOLD CORP.	Counter Torque	2016-09-12
LXH FIRST GOLD CORP.	Convex Type Shaver	2016-09-12
LXH FIRST GOLD CORP.	Compressor	2016-09-12
LXH FIRST GOLD CORP.	Closed Ring	2016-09-12
LXH FIRST GOLD CORP.	Caspa Retractor	2016-09-12
LXH FIRST GOLD CORP.	Caspa Pin	2016-09-12
LXH FIRST GOLD CORP.	Caspa Pin Driver	2016-09-12
LXH FIRST GOLD CORP.	Caspa Blade Ejector	2016-09-12
LXH FIRST GOLD CORP.	Cancellous Bone Impactor-Ball Handle	2016-09-12
LXH FIRST GOLD CORP.	Cancellous Bone Funnel	2016-09-12
LXH FIRST GOLD CORP.	COMPRESSION&DISTRACTION	2016-09-12
LXH FIRST GOLD CORP.	CANNULATED TAP	2016-09-12
LXH FIRST GOLD CORP.	CANNULATED PROBE	2016-09-12
LXH FIRST GOLD CORP.	CANNULATED AWL	2016-09-12
LXH FIRST GOLD CORP.	Bone Screw Final Driver	2016-09-12
LXH FIRST GOLD CORP.	Bone Osteotome Right	2016-09-12
LXH FIRST GOLD CORP.	Bone Osteotome Left	2016-09-12
LXH FIRST GOLD CORP.	Bone Curette Right	2016-09-12
LXH FIRST GOLD CORP.	Bone Curette Angled Left	2016-09-12
LXH FIRST GOLD CORP.	Blade	2016-09-12
LXH FIRST GOLD CORP.	Blade Retractor	2016-09-12
LXH FIRST GOLD CORP.	Awl	2016-09-12
LXH FIRST GOLD CORP.	Apollon VP Needle	2016-09-12
LXH FIRST GOLD CORP.	Apollon VP Needle Long	2016-09-12
LXH FIRST GOLD CORP.	Apollon VP Needle Long Trocar Type	2016-09-12
LXH FIRST GOLD CORP.	Apollon Screw Outer Holder	2016-09-12
LXH FIRST GOLD CORP.	Apollon Screw Inner Holder	2016-09-12
LXH FIRST GOLD CORP.	Apollon Screw Caddy	2016-09-12
LXH FIRST GOLD CORP.	Apollon Rod Caddy	2016-09-12
LXH FIRST GOLD CORP.	Apollon Nut Starter	2016-09-12
LXH FIRST GOLD CORP.	Apollon Insertion Set Wrench	2016-09-12
LXH FIRST GOLD CORP.	Apollon Holder Connector	2016-09-12
LXH FIRST GOLD CORP.	Apollon Guide Pin	2016-09-12
LXH FIRST GOLD CORP.	Apollon Dilator	2016-09-12
LXH FIRST GOLD CORP.	Apollon Container	2016-09-12
LXH FIRST GOLD CORP.	Apollon Cannula Tap	2016-09-12
LXH FIRST GOLD CORP.	Apollon Alignment Guide	2016-09-12
LXH FIRST GOLD CORP.	Apllon Dilator	2016-09-12
LXH FIRST GOLD CORP.	Anti-Torque Wrench	2016-09-12
LXH FIRST GOLD CORP.	Anatomical Cage Caddy	2016-09-12
LXH FIRST GOLD CORP.	Accessory Case	2016-09-12
LXH FIRST GOLD CORP.	ARTICULATING ROD INSERTER	2016-09-12
LXH FIRST GOLD CORP.	APOLLON Rod Insertion Set	2016-09-12
LXH FIRST GOLD CORP.	APOLLON Poly Screw Driver	2016-09-12
LXH FIRST GOLD CORP.	APOLLON Distractor	2016-09-12
LXH FIRST GOLD CORP.	APOLLON Compressor	2016-09-12
LXH FIRST GOLD CORP.	AO I-Handle	2016-09-12
LXH FIRST GOLD CORP.	4CIS Pinehurst Temporary Pin Caddy	2016-09-12
LXH FIRST GOLD CORP.	4CIS Pinehurst Temporary Fixation Pin	2016-09-12
LXH FIRST GOLD CORP.	4CIS Pinehurst Temporary Fixation Pin Inserter	2016-09-12
LXH FIRST GOLD CORP.	4CIS Pinehurst Tap 10mm	2016-09-12
LXH FIRST GOLD CORP.	4CIS Pinehurst Single DTS	2016-09-12
LXH FIRST GOLD CORP.	4CIS Pinehurst Self Constrained Awl	2016-09-12
LXH FIRST GOLD CORP.	4CIS Pinehurst Screw Driver	2016-09-12
LXH FIRST GOLD CORP.	4CIS Pinehurst Screw Caddy	2016-09-12
LXH FIRST GOLD CORP.	4CIS Pinehurst Plate Holder	2016-09-12
LXH FIRST GOLD CORP.	4CIS Pinehurst Plate Bender	2016-09-12
LXH FIRST GOLD CORP.	4CIS Pinehurst Hexlobe Screw Removal Tool	2016-09-12
LXH FIRST GOLD CORP.	4CIS Pinehurst Drill	2016-09-12
LXH FIRST GOLD CORP.	4CIS Pinehurst Drill Guide-Variable	2016-09-12
LXH FIRST GOLD CORP.	4CIS Pinehurst Drill Guide-Fixed	2016-09-12
LXH FIRST GOLD CORP.	4CIS Pinehurst Double DTS	2016-09-12
LXH FIRST GOLD CORP.	4CIS Pinehurst Case	2016-09-12
LXH FIRST GOLD CORP.	4CIS Pinehurst ACP 5Level Caddy	2016-09-12
LXH FIRST GOLD CORP.	4CIS Pinehurst ACP 4Level Caddy	2016-09-12
LXH FIRST GOLD CORP.	4CIS Pinehurst ACP 1~3Level Caddy	2016-09-12
LXH FIRST GOLD CORP.	4CIS Marlin Trial	2016-09-12
LXH FIRST GOLD CORP.	4CIS Marlin Rasp S - Lollipop	2016-09-12
LXH FIRST GOLD CORP.	4CIS Marlin Rasp L - Lollipop	2016-09-12
LXH FIRST GOLD CORP.	4CIS Marlin Cage Inserter	2016-09-12
LXH FIRST GOLD CORP.	4CIS Marlin Cage Impactor	2016-09-12
LXH FIRST GOLD CORP.	4CIS Marlin Bone Graft Holder	2016-09-12
LXH FIRST GOLD CORP.	4CIS Marlin Bone Graft Handle	2016-09-12
LXH FIRST GOLD CORP.	4.0 Hex Driver, Cannulated	2016-09-12
OAR FIRST GOLD CORP.	MEDINAUT-V	2015-07-19
PMN K133669 | NDN FIRST GOLD CORP.	MEDINAUT-X	2014-11-20
PMN K133669 | NDN FIRST GOLD CORP.	MEDINAUT-I	2014-11-20
PMN K133669 | NDN FIRST GOLD CORP.	MEDINAUT Kyphoplasty System	2014-11-20
PMN K133669 | NDN FIRST GOLD CORP.	B-Two Vertebral access system	2014-11-20
PMN K133669 | NDN FIRST GOLD CORP.	B-Two Vertebral Balloon Expand? Kyphoplasty System	2014-11-20
PMN K133669 | NDN FIRST GOLD CORP.	B-Two Inflatable bone expander system syringe	2014-11-20
PMN K133669 | NDN FIRST GOLD CORP.	B-Two Inflatable bone expander system balloon catheter	2014-11-20
PMN K133669 | HRX FIRST GOLD CORP.	MEDINAUT-X	2014-11-20
PMN K133669 | HRX FIRST GOLD CORP.	MEDINAUT-I	2014-11-20
PMN K133669 | HRX FIRST GOLD CORP.	MEDINAUT Kyphoplasty System	2014-11-20
PMN K133669 | HRX FIRST GOLD CORP.	B-Two Vertebral access system	2014-11-20
PMN K133669 | HRX FIRST GOLD CORP.	B-Two Vertebral Balloon Expand? Kyphoplasty System	2014-11-20
PMN K133669 | HRX FIRST GOLD CORP.	B-Two Inflatable bone expander system syringe	2014-11-20
PMN K133669 | HRX FIRST GOLD CORP.	B-Two Inflatable bone expander system balloon catheter	2014-11-20
PMN K121615 | MNI FIRST GOLD CORP.	4cis Vane Spine System	2013-10-23
PMN K121615 | MNH FIRST GOLD CORP.	4cis Vane Spine System	2013-10-23
PMN K102458 | MNI FIRST GOLD CORP.	4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM	2013-10-23
PMN K102458 | MNH FIRST GOLD CORP.	4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM	2013-10-23
PMN K101818 | MNI FIRST GOLD CORP.	4cis Vane Spine System	2013-10-23
PMN K101818 | MNH FIRST GOLD CORP.	4cis Vane Spine System	2013-10-23
PMN K092162 | MAX FIRST GOLD CORP.	4cis Peek, Plif And Tlif Cage System	2013-10-23
PMN K082453 | MNI FIRST GOLD CORP.	4cis Solar And Apollon Spine Systems	2013-10-23
PMN K082453 | MNH FIRST GOLD CORP.	4cis Solar And Apollon Spine Systems	2013-10-23
PMN K081145 | MNI FIRST GOLD CORP.	Modification To 4cis Vane Spine System	2013-10-23
PMN K081145 | MNH FIRST GOLD CORP.	Modification To 4cis Vane Spine System	2013-10-23
PMN K060702 | MNI FIRST GOLD CORP.	4cis Vane Spine System	2013-10-23
PMN K060702 | MNH FIRST GOLD CORP.	4cis Vane Spine System	2013-10-23
PMN K051155 | HRS FIRST GOLD CORP.	Solco 4cis General Plate System	2013-10-23
PMN K050471 | MNI FIRST GOLD CORP.	4cis Solar Spine System And 4cis Apollon	2013-10-23
PMN K050471 | MNH FIRST GOLD CORP.	4cis Solar Spine System And 4cis Apollon	2013-10-23
PMN K043578 | MNI FIRST GOLD CORP.	The 4cis Spinal System And 4cis Low Back	2013-10-23
PMN K043578 | MNH FIRST GOLD CORP.	The 4cis Spinal System And 4cis Low Back	2013-10-23

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2018031548832	Pusan,South Korea -> Los Angeles, California	INSTRUMENTS	10 CTN