FDA Device Registration & Listing · Emmingen Baden-Wurttemberg, DE · Registration 3031240334
Normalized identity and public registration information from FDA records.
No proprietary names listed under this establishment.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2025-07-07 |
| HXZ | Cutter, Wire | Orthopedic | Class 1 | 888.4540 | 2025-07-07 |
| GFA | Blade, Saw, General & Plastic Surgery, Surgical | General, Plastic Surgery | Class 1 | 878.4820 | 2025-07-07 |
| NBH | Accessories, Arthroscopic | Orthopedic | Class 1 | 888.1100 | 2025-07-07 |
| FZT | Cutter, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2025-07-07 |
| HXI | Passer, Wire, Orthopedic | Orthopedic | Class 1 | 888.4540 | 2025-07-07 |
| HWA | Impactor | Orthopedic | Class 1 | 888.4540 | 2025-07-07 |
| HTN | Washer, Bolt Nut | Orthopedic | Class 2 | 888.3030 | 2025-07-07 |
| JDW | Pin, Fixation, Threaded | Orthopedic | Class 2 | 888.3040 | 2025-07-07 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2025-07-07 |
| JDQ | Cerclage, Fixation | Orthopedic | Class 2 | 888.3010 | 2025-07-07 |
| HTY | Pin, Fixation, Smooth | Orthopedic | Class 2 | 888.3040 | 2025-07-07 |
| GEG | Elevator, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2025-03-05 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | Orthopedic | Class 2 | 888.3030 | 2025-07-07 |
| HTN | Washer, Bolt Nut | Orthopedic | Class 2 | 888.3030 | 2025-07-07 |
| HRS | Plate, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2025-07-07 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2025-07-07 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Orthopedic | Class 2 | 888.3080 | 2025-07-07 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2025-07-07 |
| FCL | Forceps, Biopsy, Non-Electric | Gastroenterology, Urology | Class 1 | 876.1075 | 2025-07-07 |
| FDC | Resectoscope, Working Element | Gastroenterology, Urology | Class 2 | 876.1500 | 2025-07-07 |
| FAS | Electrode, Electrosurgical, Active, Urological | Gastroenterology, Urology | Class 2 | 876.4300 | 2025-07-07 |
| FJL | Resectoscope | Gastroenterology, Urology | Class 2 | 876.1500 | 2025-07-07 |
| GFF | Bur, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4820 | 2025-07-07 |
| GAD | Retractor | General, Plastic Surgery | Class 1 | 878.4800 | 2025-07-07 |
| DWG | Electrosurgical Device | General, Plastic Surgery | Class 2 | 878.4400 | 2025-07-07 |
| HTT | Burr, Orthopedic | Orthopedic | Class 1 | 888.4540 | 2025-03-05 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2025-07-07 |
| HWR | Driver, Prosthesis | Orthopedic | Class 1 | 888.4540 | 2025-07-07 |
| GDI | Dissector, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2025-07-07 |
| HXL | Mallet | General, Plastic Surgery | Class 1 | 878.4800 | 2025-07-07 |
| GEA | Cannula, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2025-07-07 |
| GFC | Driver, Surgical, Pin | General, Plastic Surgery | Class 1 | 878.4820 | 2025-07-07 |
| HTC | Pliers, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2025-07-07 |
| HTF | Curette | General, Plastic Surgery | Class 1 | 878.4800 | 2025-07-07 |
| HXC | Wrench | Orthopedic | Class 1 | 888.4540 | 2025-07-07 |
| GEN | Forceps, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2025-07-07 |
| FZO | Chisel, Surgical, Manual | General, Plastic Surgery | Class 1 | 878.4800 | 2025-07-07 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2025-07-07 |
| HTD | Forceps | General, Plastic Surgery | Class 1 | 878.4800 | 2025-07-07 |
| HWN | Instrument, Compression | Orthopedic | Class 1 | 888.4540 | 2025-07-07 |
| JDW | Pin, Fixation, Threaded | Orthopedic | Class 2 | 888.3040 | 2025-07-07 |
| HTY | Pin, Fixation, Smooth | Orthopedic | Class 2 | 888.3040 | 2025-07-07 |
| FSM | Tray, Surgical, Instrument | General, Plastic Surgery | Class 1 | 878.4800 | 2025-07-07 |
| EBL | Pin, Retentive And Splinting, And Accessory Instruments | Dental | Class 1 | 872.3740 | 2025-07-07 |
| HTJ | Gauge, Depth | Orthopedic | Class 1 | 888.4300 | 2025-07-07 |
| GDZ | Handle, Scalpel | General, Plastic Surgery | Class 1 | 878.4800 | 2025-03-05 |
| FZX | Guide, Surgical, Instrument | General, Plastic Surgery | Class 1 | 878.4800 | 2025-07-07 |
| HWM | Osteotome | General, Plastic Surgery | Class 1 | 878.4800 | 2025-07-07 |
| HYA | Forceps, Wire Holding | General, Plastic Surgery | Class 1 | 878.4800 | 2025-07-07 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2025-07-07 |
| HRS | Plate, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2025-07-07 |
| HTY | Pin, Fixation, Smooth | Orthopedic | Class 2 | 888.3040 | 2025-07-07 |
| GAC | Rasp, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2025-07-07 |
| HXW | Bender | Orthopedic | Class 1 | 888.4540 | 2025-07-07 |
| LXH | Orthopedic Manual Surgical Instrument | Orthopedic | Class 1 | 888.4540 | 2025-07-07 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2025-07-07 |
| KAI | Mirror, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2025-07-07 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | Class 2 | 888.3060 | 2025-07-07 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2025-07-07 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2025-07-07 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2025-07-07 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Orthopedic | Class 2 | 888.3050 | 2025-07-07 |
| HTW | Bit, Drill | Orthopedic | Class 1 | 888.4540 | 2025-01-29 |
| HFB | Forceps, Biopsy, Gynecological | Obstetrics/Gynecology | Class 1 | 884.4530 | 2025-07-07 |
| HWX | Tap, Bone | Orthopedic | Class 1 | 888.4540 | 2025-03-05 |
| HAB | Saw, Powered, And Accessories | General, Plastic Surgery | Class 1 | 878.4820 | 2025-07-07 |
| FWF | Camera, Television, Endoscopic, Without Audio | General, Plastic Surgery | Class 1 | 878.4160 | 2025-07-07 |
| JDR | Staple, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2025-07-07 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2025-07-07 |
| HRS | Plate, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2025-07-07 |
| FHQ | Holder, Needle, Gastroenterologic | Gastroenterology, Urology | Class 1 | 876.4730 | 2025-07-07 |
| LRP | Tray, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2025-07-07 |
| KIK | Hook, Bone | General, Plastic Surgery | Class 1 | 878.4800 | 2025-07-07 |
| HXP | Instrument, Bending Or Contouring | Orthopedic | Class 1 | 888.4540 | 2025-07-07 |
| HTO | Reamer | Orthopedic | Class 1 | 888.4540 | 2025-03-05 |
No official correspondent registered.
| 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 |
| 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 |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3013843055 | BEIJING AK MEDICAL CO, LTD | Changping District Beijing, CN |
| 3022777867 | FIXIER S.A. DE C.V. | Doctor Mora Guanajuato, MX |
| 3017209758 | NEBULA SURGICAL PRIVATE LIMITED | Rajkot Gujarat, IN |
| 3015410662 | Jabil Inc. (Wilson Drive) | W Chester, PA, US |
| 8043862 | AAP IMPLANTATE AG | BERLIN, DE |
3031240334 when referencing this establishment in official correspondence.