Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006272282

FEI Number

3006272282

Entity Name

HG Medical GmbH

City/State/Country

Raisting Bavaria, DE

Establishment Address

Gewerbegebiet 16, Raisting Bavaria 82399, DE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

hg medical GmbH (Owner Number: 10023065)

Owner / Operator Contact Address

hg medical GmbH, Gewerbegebiet 16, Raisting, DE-BY 82399, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Omni System TMC Prong Stapels with inserters Hockey Plating System Dyna Force System Snap Off Screws Micronail Cleaning Stylet Lapidus Plantar Plate Short - Arthrex Drill Guide Bone Fragment Pick Screw Gripper K-Wire Countersink Plate Tray, Instrument Tray, Screw Tray Distal Fibular Plate - Arthrex Beam / Bolt Screws Tenotac Swivel Darco Headed Screws Paragon P53-207** Fastener, Fixation, Nondegradable, Soft Tissue System Rayhack System Wright DHP Plate System APS Plates Calcaneal Fracture System Paragon - Monster Bite Screws Bone screw system CLC Frac Plate Dynamic Nail WMT ANT Platten Zadex/Titanex Screw System CrossRoads Headed 3 / 4 Snap-Off Screws Valor Ankle Fusion Nail System Arthrex - Peripheral Schrauben Dynamet MDS Broad and Narrow Plates Screw Bone Reduction Clamp Forceps Washer Smooth or threaded metallic bone fixation fastener Elbow Fracture Plating System Medline - SnapOff Cortical Screw Full Arthrex Headless Comp. Screw Paragon Baby Gorilla Platten Dynaforce Rizzo TMC Implant Fixation System HTO Freecut Technique Keyhole Guide Locon - T Quick MTP implants and instruments FIxation Pin Washer Bone Screw System Succession AFN System Dynamic IOL TMC Anatomical Akin Medline MTP Plate System Plate, Medial Malleolus 3Di Plates El Capitan X System Rapid TenoTac Implants Phantom Nail Static Nails Lisfranc EFS LAG Screw; Weil Screw; Nail Plate Screw; GEN I Plates / Screws Driver Drive Star Dunamis Screw and Suture Locking System Beveled Screws TWF Plating System Acumed ORTHOLOC 3DI HALLUX SYSTEM Synergy Compression Screws Wright-HV Screws MIS Screw System Alpha Lock System Medline MPPA / Cancellous / Hock Salvation Nail SMN Posteriolateral Plates - Arthrex Proximal Humerus Plate System Digital Fusion Screw Phantom 2 Low Pro Cort Screw MDS Proximal Humerus DARCO Force Compression Screw MicroNail Temp Fix Pin Talar Smooth or threaded metallic bone fixation fastener, Washer MDS Olecranon Locking Screw Valor Screw Mesh Plate System TC Plating System (OrthoPro) Mini Plates and Screws ORTHOLOC 3DI Midfoot/Flatfoot System DARCO Locking Bone Plate System MIS Arhtrex Intramedullary Nails Lapidus Nail System - Paragon Jones Screw ParaLock Plating System and Plate Screws Plantar Lapidus Plate - Arthrex Depth Guide Depth Gage CrossRoads - 3,5 Non-Locking, 3,0 Locking, MotoBand-CP Plates Anterior Staple Drills Distal Radius Plating System Summit Patella Plating System Variable Angle Small Fragment locking plate system Arthrex - Mesh Plate Oxford AFN 5; End Caps ZION Anterior Cervical Fixation System Silverback CrossRoads Headed 5 / 6.5 Mini Monster

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2025-07-08
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2025-07-08
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2023-01-18
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2021-11-17
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-11-17
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2019-04-04
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-04-04
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2019-03-13
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2019-03-13
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-03-13
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2019-03-13
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2017-01-25
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2010-03-02
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2010-03-02
HXZ	Cutter, Wire	Orthopedic	Class 1	888.4540	2021-11-19
HWW	Countersink	Orthopedic	Class 1	888.4540	2010-03-02
LRP	Tray, Surgical	General, Plastic Surgery	Class 1	878.4800	2010-03-02
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2016-11-15
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2014-08-08
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2021-07-08
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2013-11-04
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2019-05-15
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2019-05-15
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-05-15
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2026-03-11
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2026-03-11
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2016-06-22
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2022-05-06
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-03-13
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2022-03-04
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2018-03-23
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2025-12-04
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-03-13
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2020-02-03
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2020-02-03
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2018-05-04
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2025-03-07
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2015-10-09
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2019-06-26
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2009-10-14
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2018-04-24
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2023-12-04
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2023-12-04
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2018-05-18
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-02-01
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2010-03-02
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2009-10-14
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2024-11-21
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2017-08-22
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-03-13
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2019-03-13
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2015-10-09
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2019-05-15
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-05-15
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2019-05-15
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-06-26
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2019-06-26
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2025-12-04
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2025-12-04
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2025-12-04
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2010-03-02
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2024-09-12
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2024-09-12
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2019-03-13
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-04-05
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2022-04-05
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2025-12-04
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2026-05-05
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2022-11-03
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2025-01-17
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2015-08-07
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2015-08-07
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2022-10-21
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-03-13
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2025-12-16
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-12-20
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2016-04-06
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2016-04-06
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2019-08-05
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2019-09-27
KTW	Appliance, Fixation, Nail/Blade/Plate Combination, Single Component	Orthopedic	Class 2	888.3030	2019-09-27
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2019-11-04
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2019-11-04
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2021-10-13
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-10-13
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2015-05-20
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2015-05-20
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2015-05-20
HWR	Driver, Prosthesis	Orthopedic	Class 1	888.4540	2010-03-02
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2026-03-11
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2026-03-11
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2026-03-11
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-07-08
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2014-05-05
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2014-05-05
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2012-11-02
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2023-10-12
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2023-10-12
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2019-04-04
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2018-04-26
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2026-04-29
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2026-04-29
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2026-04-29
KTW	Appliance, Fixation, Nail/Blade/Plate Combination, Single Component	Orthopedic	Class 2	888.3030	2026-04-29
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2026-04-29
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2026-04-29
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2022-08-18
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-08-18
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2016-12-12
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2016-12-12
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2019-03-13
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2016-11-11
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2024-12-02
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2024-12-02
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-02-24
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2021-11-30
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-03-13
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2019-03-13
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2018-05-02
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2007-11-01
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2015-01-28
HSN	Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3110	2015-01-28
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2013-06-11
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2018-05-02
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2018-05-02
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-12-20
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2021-12-20
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2019-03-13
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-03-01
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2021-03-01
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2015-02-02
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2018-11-02
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2018-11-02
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2012-11-02
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2007-11-01
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2024-08-09
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2026-05-26
KTW	Appliance, Fixation, Nail/Blade/Plate Combination, Single Component	Orthopedic	Class 2	888.3030	2017-07-06
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2017-07-06
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2020-06-18
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2020-06-18
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2014-05-05
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2014-05-05
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2014-05-05
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2015-05-20
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2015-05-20
HTJ	Gauge, Depth	Orthopedic	Class 1	888.4300	2010-03-02
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2017-08-02
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2017-08-02
PHQ	Anterior Staple As Supplemental Fixation For Fusion	Orthopedic	Class 2	888.3060	2021-09-16
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2022-08-11
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-08-11
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2026-05-27
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2026-05-27
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2025-12-04
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2025-12-04
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2017-09-08
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2015-05-20
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2025-12-04
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2020-10-08
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2015-10-09
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2020-01-16

Official Correspondent

No official correspondent registered.

US Agent Details

Christina Craigo Business: HG Medical USA Email: jhunter@hg-medical.com Phone: (304) 6901943

Related Public Records

Same Entity

hg medical GmbH

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K062348	Medtronic Neurosurgery	TIMESH SELF DRILLING SCREW	2006-09-08
K063244	Arc Surgical, LLC	ARC SURGICAL BONE REDUCTION SCREW	2006-12-27
K972722	Orthopedic Designs, Inc.	ULTIMATE COMPRESSION SCREW SYSTEM	1998-01-23
K192974	Tyber Medical, LLC	Tyber Medical Trauma Screw	2020-01-08
K082949	OrthoPediatrics Corp.	ORTHOPEDIATRICS BONE SCREWS	2008-11-25

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0014-2014	Synthes USA HQ, Inc.	2	Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Z-0026-2013	Orthohelix Surgical Designs Inc	2	OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0026-2016	Ortho Solutions Inc 330 Franklin Tnpk	2	Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw
Z-0027-2013	Orthohelix Surgical Designs Inc	2	OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0043-2018	MicroPort Orthopedics Inc.	2	MicroPort Orthopedics SCHANZ SCREW SELF DRILL, SIZE 4mm, REF 20070057, STERILE R Product Usage: MPO Total Hip Systems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006272282. Last updated year: 2026. Please use registration number 3006272282 when referencing this establishment in official correspondence.