Hg Medical G M B H

FDA Filings

This page includes the latest FDA filings for Hg Medical G M B H. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3006272282
• FEI Number: 3006272282
• Name: Mark Cooper
• Owner & Operator: HG Medical GmbH
• Contact Address: HG Medical GmbH Gewerbegebiet 16; Raisting DE-BY Bayern 82399 DE
• Official Correspondent:
  • Michael Visino
  • 049-8807-214343-26
• US Agent:
  • Mark Cooper
  • Darco International, Inc.
  • 304 5224883
  • 304 5220037
  • mcooper@darcointernational.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 810 Memorial Blvd ; Huntington, WV 25701 US
• Establishment Type:
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Export Device to the United States But Perform No Other Operation on Device
  • Manufacture Medical Device

FDA Filings

Device Company	Device	Date
PMN K192163 | HWC Mark Cooper [HG Medical GmbH]	Dynamic Nail	2020-02-03
PMN K192163 | HSB Mark Cooper [HG Medical GmbH]	Dynamic Nail	2020-02-03
PMN K193452 | JDR Mark Cooper [HG Medical GmbH]	Dynaforce	2020-01-29
PMN K193452 | HWC Mark Cooper [HG Medical GmbH]	Dynaforce	2020-01-29
PMN K193452 | HRS Mark Cooper [HG Medical GmbH]	Dynaforce	2020-01-29
PMN K190586 | HWC Mark Cooper [HG Medical GmbH]	Mini Monster	2020-01-16
PMN K191782 | HWC Mark Cooper [HG Medical GmbH]	Static Nails	2019-11-04
PMN K191782 | HSB Mark Cooper [HG Medical GmbH]	Static Nails	2019-11-04
PMN K182307 | KTW Mark Cooper [HG Medical GmbH]	Phantom Nail	2019-09-27
PMN K182307 | HWC Mark Cooper [HG Medical GmbH]	Phantom Nail	2019-09-27
PMN K182898 | MBI Mark Cooper [HG Medical GmbH]	TenoTac Implants	2019-08-05
PMN K183363 | HWC Mark Cooper [HG Medical GmbH]	Snap-Off Screws	2019-06-26
PMN K160300 | HWC Mark Cooper [HG Medical GmbH]	Dynaforce Rizzo	2019-06-26
PMN K160300 | HRS Mark Cooper [HG Medical GmbH]	Dynaforce Rizzo	2019-06-26
PMN K190365 | HWC Mark Cooper [HG Medical GmbH]	Paragon P53-207**	2019-05-15
PMN K190365 | HTN Mark Cooper [HG Medical GmbH]	Paragon P53-207**	2019-05-15
PMN K190365 | HRS Mark Cooper [HG Medical GmbH]	Paragon P53-207**	2019-05-15
PMN K172886 | HWC Mark Cooper [HG Medical GmbH]	Paragon Baby Gorilla Platten	2019-05-15
PMN K172886 | HTN Mark Cooper [HG Medical GmbH]	Paragon Baby Gorilla Platten	2019-05-15
PMN K172886 | HRS Mark Cooper [HG Medical GmbH]	Paragon Baby Gorilla Platten	2019-05-15
PMN K141478 | HWC Mark Cooper [HG Medical GmbH]	Locking Distal Fibula System	2019-04-30
PMN K141478 | HRS Mark Cooper [HG Medical GmbH]	Locking Distal Fibula System	2019-04-30
PMN K173710 | HWC Mark Cooper [HG Medical GmbH]	Dyna Force System	2019-04-04
PMN K173710 | HRS Mark Cooper [HG Medical GmbH]	Dyna Force System	2019-04-04
PMN K172617 | HWC Mark Cooper [HG Medical GmbH]	Compression Screws	2019-04-04
PMN K180024 | HWC Mark Cooper [HG Medical GmbH]	Salvation Nail SMN	2019-03-13
PMN K163044 | HWC Mark Cooper [HG Medical GmbH]	Cortical Screw Full	2019-03-13
PMN K163044 | HRS Mark Cooper [HG Medical GmbH]	Cortical Screw Full	2019-03-13
PMN K163039 | HRS Mark Cooper [HG Medical GmbH]	3Di Plates	2019-03-13
PMN K150073 | HSB Mark Cooper [HG Medical GmbH]	Micronail	2019-03-13
PMN K142121 | HRS Mark Cooper [HG Medical GmbH]	CLC Frac Plate	2019-03-13
PMN K133713 | HWC Mark Cooper [HG Medical GmbH]	Snap Off Screws	2019-03-13
PMN K131093 | HRS Mark Cooper [HG Medical GmbH]	APS Plates	2019-03-13
PMN K120802 | HWC Mark Cooper [HG Medical GmbH]	Low Pro Cort Screw	2019-03-13
PMN K120802 | HRS Mark Cooper [HG Medical GmbH]	Low Pro Cort Screw	2019-03-13
PMN K111432 | HWC Mark Cooper [HG Medical GmbH]	Cleaning Stylet	2019-03-13
PMN K111432 | HRS Mark Cooper [HG Medical GmbH]	Cleaning Stylet	2019-03-13
PMN K110522 | KWP Mark Cooper [HG Medical GmbH]	Valor Screw	2019-03-13
PMN K051017 | KTT Mark Cooper [HG Medical GmbH]	FIxation Pin	2019-03-13
HXX Mark Cooper [HG Medical GmbH]	Medline Screwdriver MPN3000X / MSN3000X	2019-01-31
PMN K181820 | HWC Mark Cooper [HG Medical GmbH]	Mini Plates and Screws	2018-11-02
PMN K181820 | HRS Mark Cooper [HG Medical GmbH]	Mini Plates and Screws	2018-11-02
PMN K172786 | HRS Mark Cooper [HG Medical GmbH]	MDS Broad and Narrow Plates	2018-05-18
PMN K163650 | HRS Mark Cooper [HG Medical GmbH]	WMT ANT Platten	2018-05-04
PMN K121425 | HRS Mark Cooper [HG Medical GmbH]	WMT ANT Platten	2018-05-04
PMN K162898 | HWC Mark Cooper [HG Medical GmbH]	MDS Olecranon	2018-05-02
PMN K162898 | HRS Mark Cooper [HG Medical GmbH]	MDS Olecranon	2018-05-02
PMN K141493 | HRS Mark Cooper [HG Medical GmbH]	MDS Proximal Humerus	2018-05-02
PMN K170889 | HWC Mark Cooper [HG Medical GmbH]	Wright-HV Screws	2018-04-26
PMN K173900 | PHX Mark Cooper [HG Medical GmbH]	Arthrex - Peripheral Schrauben	2018-04-24
PMN K153531 | HWC Mark Cooper [HG Medical GmbH]	Treace - Python Plates and Screws	2018-04-20
PMN K153531 | HRS Mark Cooper [HG Medical GmbH]	Treace - Python Plates and Screws	2018-04-20
PMN K153378 | HWC Mark Cooper [HG Medical GmbH]	Paragon - Monster Bite Screws	2018-03-23
PMN K151418 | HWC Mark Cooper [HG Medical GmbH]	Paragon - Monster Screws and Washers	2018-03-23
PMN K151418 | HTN Mark Cooper [HG Medical GmbH]	Paragon - Monster Screws and Washers	2018-03-23
PMN K170547 | HRS Mark Cooper [HG Medical GmbH]	Arthrex - Mesh Plate	2017-09-08
PMN K170782 | HWC Mark Cooper [HG Medical GmbH]	Medline - SnapOff	2017-08-22
PMN K152306 | HWC Mark Cooper [HG Medical GmbH]	CrossRoads - 3,5 Non-Locking, 3,0 Locking, MotoBand-CP Plates	2017-08-02
PMN K152306 | HRS Mark Cooper [HG Medical GmbH]	CrossRoads - 3,5 Non-Locking, 3,0 Locking, MotoBand-CP Plates	2017-08-02
PMN K170693 | KTW Mark Cooper [HG Medical GmbH]	Lapidus Nail System - Paragon	2017-07-06
PMN K170693 | HWC Mark Cooper [HG Medical GmbH]	Lapidus Nail System - Paragon	2017-07-06
PMN K143717 | HWC Mark Cooper [HG Medical GmbH]	Treace - Python/Curved/Screws	2017-02-27
PMN K143717 | HRS Mark Cooper [HG Medical GmbH]	Treace - Python/Curved/Screws	2017-02-27
PMN K150456 | HRS Mark Cooper [HG Medical GmbH]	Lapidus Plantar Plate Short - Arthrex	2017-01-25
PMN K162829 | HWC Mark Cooper [HG Medical GmbH]	Medline MPPA / Cancellous / Hock	2016-12-12
PMN K162829 | HRS Mark Cooper [HG Medical GmbH]	Medline MPPA / Cancellous / Hock	2016-12-12
PMN K052614 | HRS Mark Cooper [HG Medical GmbH]	Distal Fibular Plate - Arthrex	2016-11-15
PMN K151732 | HRS Mark Cooper [HG Medical GmbH]	Posteriolateral Plates - Arthrex	2016-11-11
PMN K913930 | HRS Mark Cooper [HG Medical GmbH]	Rayhack System Wright	2016-06-22
PMN K152072 | HWC Mark Cooper [HG Medical GmbH]	CrossRoads Headed 5.0 / 6.5	2015-10-09
PMN K143039 | HWC Mark Cooper [HG Medical GmbH]	CrossRoads Headed 3.0 / 4.0	2015-10-09
PMN K132217 | HWC Mark Cooper [HG Medical GmbH]	Arthrex Headless Comp. Screw	2015-10-09
PMN K151235 | HWC Mark Cooper [HG Medical GmbH]	Medline MTP Plate System	2015-08-07
PMN K151235 | HRS Mark Cooper [HG Medical GmbH]	Medline MTP Plate System	2015-08-07
PMN K141784 | KTT Mark Cooper [HG Medical GmbH]	GEN II Screws / Plates; 3.5 Cannulated Screws	2015-05-20
PMN K141784 | HWC Mark Cooper [HG Medical GmbH]	GEN II Screws / Plates; 3.5 Cannulated Screws	2015-05-20
PMN K141784 | HRS Mark Cooper [HG Medical GmbH]	GEN II Screws / Plates; 3.5 Cannulated Screws	2015-05-20
PMN K121575 | HSB Mark Cooper [HG Medical GmbH]	Oxford AFN 5.0; End Caps	2015-05-20
PMN K111678 | JDR Mark Cooper [HG Medical GmbH]	EFS LAG Screw; Weil Screw; Nail Plate Screw; GEN I Plates / Screws	2015-05-20
PMN K111678 | HWC Mark Cooper [HG Medical GmbH]	EFS LAG Screw; Weil Screw; Nail Plate Screw; GEN I Plates / Screws	2015-05-20
PMN K111678 | HRS Mark Cooper [HG Medical GmbH]	EFS LAG Screw; Weil Screw; Nail Plate Screw; GEN I Plates / Screws	2015-05-20
PMN K111253 | HWC Mark Cooper [HG Medical GmbH]	Plantar Lapidus Plate - Arthrex	2015-05-20
PMN K111253 | HRS Mark Cooper [HG Medical GmbH]	Plantar Lapidus Plate - Arthrex	2015-05-20
PMN K094037 | HRS Mark Cooper [HG Medical GmbH]	TC Plating System (OrthoPro)	2015-02-02
PMN K140749 | HSN Mark Cooper [HG Medical GmbH]	Pin 3,2 Infinity	2015-01-28
PMN K123954 | HSN Mark Cooper [HG Medical GmbH]	Temp Fix Pin Talar	2015-01-28
PMN K040938 | HRS Mark Cooper [HG Medical GmbH]	MicroNail	2015-01-28
PMN K140741 | HWC Mark Cooper [HG Medical GmbH]	Beam / Bolt Screws	2014-08-08
PMN K140397 | HWC Mark Cooper [HG Medical GmbH]	ParaLock Plating System and Plate Screws	2014-05-05
PMN K140397 | HTN Mark Cooper [HG Medical GmbH]	ParaLock Plating System and Plate Screws	2014-05-05
PMN K140397 | HRS Mark Cooper [HG Medical GmbH]	ParaLock Plating System and Plate Screws	2014-05-05
PMN K131380 | HWC Mark Cooper [HG Medical GmbH]	TWF Plating System Acumed	2014-05-05
PMN K131380 | HRS Mark Cooper [HG Medical GmbH]	TWF Plating System Acumed	2014-05-05
PMN K124027 | HWC Mark Cooper [HG Medical GmbH]	Headed_Headless 3.5/4.0; MonsterBites (P28)	2014-03-21
PMN K124027 | HTN Mark Cooper [HG Medical GmbH]	Headed_Headless 3.5/4.0; MonsterBites (P28)	2014-03-21
PMN K100359 | HWC Mark Cooper [HG Medical GmbH]	Darco Headed Screws	2013-11-04
PMN K130319 | HWC Mark Cooper [HG Medical GmbH]	Smooth or threaded metallic bone fixation fastener, Washer	2013-06-11
PMN K121651 | HRS Mark Cooper [HG Medical GmbH]	ORTHOLOC 3DI Midfoot/Flatfoot System	2012-11-02
PMN K120359 | HRS Mark Cooper [HG Medical GmbH]	ORTHOLOC 3DI HALLUX SYSTEM	2012-11-02
PMN K102429 | HWC Mark Cooper [HG Medical GmbH]	ORTHOLOC 3DI ANKLE PLATING SYSTEM, ORTHOLOC BONE SCREW	2011-10-14
PMN K102429 | HRS Mark Cooper [HG Medical GmbH]	ORTHOLOC 3DI ANKLE PLATING SYSTEM, ORTHOLOC BONE SCREW	2011-10-14
MDM Mark Cooper [HG Medical GmbH]	Locon - T Quick	2010-03-02
MDM Mark Cooper [HG Medical GmbH]	HTO Freecut Technique Keyhole Guide	2010-03-02
LXH Mark Cooper [HG Medical GmbH]	Screw Gripper	2010-03-02
LXH Mark Cooper [HG Medical GmbH]	Bone Fragment Pick	2010-03-02
LRP Mark Cooper [HG Medical GmbH]	Plate Tray, Instrument Tray, Screw Tray	2010-03-02
HWW Mark Cooper [HG Medical GmbH]	Countersink	2010-03-02
HWR Mark Cooper [HG Medical GmbH]	Driver	2010-03-02
HWR Mark Cooper [HG Medical GmbH]	Drive Star	2010-03-02
HWE Mark Cooper [HG Medical GmbH]	K-Wire	2010-03-02
HWE Mark Cooper [HG Medical GmbH]	Cleaning Stylet	2010-03-02
HWE Mark Cooper [HG Medical GmbH]	AO Quick Connect	2010-03-02
HTJ Mark Cooper [HG Medical GmbH]	Depth Guide	2010-03-02
HTJ Mark Cooper [HG Medical GmbH]	Depth Gage	2010-03-02
HTD Mark Cooper [HG Medical GmbH]	Forceps	2010-03-02
HTD Mark Cooper [HG Medical GmbH]	Bone Reduction Clamp	2010-03-02
FZX Mark Cooper [HG Medical GmbH]	Drill Guide	2010-03-02
GFG Mark Cooper [HG Medical GmbH]	Drill	2010-03-01
GFG Mark Cooper [HG Medical GmbH]	Drill Bit	2010-03-01
PMN K091243 | HWC Mark Cooper [HG Medical GmbH]	Ortholoc Ankle Plating System	2009-10-14
PMN K091243 | HRS Mark Cooper [HG Medical GmbH]	Ortholoc Ankle Plating System	2009-10-14
PMN K090857 | HSB Mark Cooper [HG Medical GmbH]	Valor Ankle Fusion Nail System	2009-10-14
PMN K090692 | HWC Mark Cooper [HG Medical GmbH]	Ortholoc 2.0/2.4 Plate System	2009-10-14
PMN K090692 | HRS Mark Cooper [HG Medical GmbH]	Ortholoc 2.0/2.4 Plate System	2009-10-14
PMN K082320 | HWC Mark Cooper [HG Medical GmbH]	Washer	2009-10-14
PMN K082320 | HWC Mark Cooper [HG Medical GmbH]	Smooth or threaded metallic bone fixation fastener	2009-10-14
PMN K062103 | HWC Mark Cooper [HG Medical GmbH]	DARCO Force Compression Screw	2007-11-01
PMN K061808 | HRS Mark Cooper [HG Medical GmbH]	DARCO Locking Bone Plate System	2007-11-01