FDA Registration
Active
🇩🇪 Germany
HG Medical GmbH
Reg #: 3006272282
·
FEI: 3006272282
·
Expires 2026
Products
31
Proprietary Names
146
Establishment Types
3
Classifications
31
Registration Details
- Registration Name
- HG Medical GmbH
- Registration Number
- 3006272282
- FEI Number
- 3006272282
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Gewerbegebiet 16
- City
- Raisting Bavaria
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K131474
Owner / Operator
- Firm Name
- hg medical GmbH
- Operator Number
- 10023065
- Address
- hg medical GmbH, Gewerbegebiet 16
- City
- Raisting
- State
- Bavaria
- Postal Code
- 82399
- Country
- DE
US Agent
- Business Name
- HG Medical USA
- Contact Name
- Christina Craigo
- Address
- 701 S Waverly Rd Ste 350
- City
- Holland
- State
- MI
- ZIP
- 49423
- Country
- US
- [email protected]
- Phone
- 304 6901943
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2025-07-08 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2025-07-08 |
| Staple, Fixation, Bone | JDR | Class 2 | Orthopedic | No | 2023-01-18 |
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2019-03-13 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2010-03-02 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2010-03-02 |
| Cutter, Wire | HXZ | Class 1 | Orthopedic | No | 2021-11-19 |
| Countersink | HWW | Class 1 | Orthopedic | No | 2010-03-02 |
| Tray, Surgical | LRP | Class 1 | General, Plastic Surgery | No | 2010-03-02 |
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | Class 2 | Orthopedic | No | 2021-07-08 |
| Washer, Bolt Nut | HTN | Class 2 | Orthopedic | No | 2019-05-15 |
| Shoulder Prosthesis, Reverse Configuration | PHX | Class 2 | Orthopedic | No | 2018-04-24 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2010-03-02 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2010-03-02 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | Class 2 | Orthopedic | No | 2019-03-13 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2025-12-16 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Single Component | KTW | Class 2 | Orthopedic | No | 2019-09-27 |
| Driver, Prosthesis | HWR | Class 1 | Orthopedic | No | 2010-03-02 |
| Suture, Nonabsorbable, Synthetic, Polyethylene | GAT | Class 2 | General, Plastic Surgery | No | 2026-03-11 |
| Pin, Fixation, Smooth | HTY | Class 2 | Orthopedic | No | 2026-04-29 |
| Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | HSN | Class 2 | Orthopedic | No | 2015-01-28 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2019-03-13 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2010-03-02 |
| Anterior Staple As Supplemental Fixation For Fusion | PHQ | Class 2 | Orthopedic | No | 2021-09-16 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2025-12-04 |
| Bit, Surgical | GFG | Class 1 | General, Plastic Surgery | No | 2010-03-01 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2010-03-02 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2019-01-31 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2025-12-04 |
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | OSH | Class 2 | Orthopedic | No | 2025-12-04 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2025-12-04 |
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
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
REDEMPTION Beaming System
Screw and Plate System
Drill
Drill Bit
Anatomical Staple
Headed_Headless 3.5/4; MonsterBites (P28)
Ortholoc 2/2.4 Plate System
Silverback Plating System
Locking Distal Fibula System
Pin 3,2 Infinity
Ortholoc Ankle Plating System
AO Quick Connect
Medline Driver
Posterior Spinal Fixation System
Ankle Fusion
Paragon - Monster Screws and Washers
ORTHOLOC 3DI ANKLE PLATING SYSTEM, ORTHOLOC BONE SCREW
Plating System
Phantom Fibula Nail System
Distal Medial Tib Osteotomy Plate
Treace - Python Plates and Screws
GEN II Screws / Plates; 3.5 Cannulated Screws
Cannulated Screws
TMC MIS SCREW
Fibula Implant System
Nanoplasty System
Treace - Python/Curved/Screws
ALPHALOK Plating System
Dynaforce
Phantom TTC/TC Nail System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device