FDA Device Registration & Listing · MUHLHEIM Baden-Wurttemberg, DE · Registration 9680619
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| MDM | Instrument, Manual, Surgical, General Use | General, Plastic Surgery | Class 1 | 878.4800 | 2024-01-16 |
| HXB | Probe | Orthopedic | Class 1 | 888.4540 | 2014-03-18 |
| HTC | Pliers, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 1994-04-15 |
| HXW | Bender | Orthopedic | Class 1 | 888.4540 | 2013-02-08 |
| LYS | Bone Mill | Orthopedic | Class 1 | 888.4540 | 2024-03-28 |
| KTZ | Caliper | Orthopedic | Class 1 | 888.4150 | 1997-12-04 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2013-05-15 |
| HTN | Washer, Bolt Nut | Orthopedic | Class 2 | 888.3030 | 2013-05-15 |
| HWE | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | General, Plastic Surgery | Class 1 | 878.4820 | 2013-11-19 |
| HTJ | Gauge, Depth | Orthopedic | Class 1 | 888.4300 | 2013-01-10 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2013-01-09 |
| HRS | Plate, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2013-01-09 |
| FZX | Guide, Surgical, Instrument | General, Plastic Surgery | Class 1 | 878.4800 | 2013-11-19 |
| DTS | Sucker, Cardiotomy Return, Cardiopulmonary Bypass | Cardiovascular | Class 2 | 870.4420 | 2025-07-03 |
| HTW | Bit, Drill | Orthopedic | Class 1 | 888.4540 | 2013-02-08 |
| HRS | Plate, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2013-01-21 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2013-01-21 |
| JEX | Plier, Orthodontic | Dental | Class 1 | 872.4565 | 2013-01-11 |
| HXX | Screwdriver | Orthopedic | Class 1 | 888.4540 | 1997-12-04 |
| HAO | Instrument, Surgical, Non-Powered | Neurology | Class 1 | 882.4535 | 1997-12-04 |
| FZT | Cutter, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2013-01-10 |
| HXD | Clamp | General, Plastic Surgery | Class 1 | 878.4800 | 2013-02-27 |
| GDL | Needle, Suturing, Reusable | General, Plastic Surgery | Class 1 | 878.4800 | 2014-04-11 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | Orthopedic | Class 2 | 888.3030 | 2014-11-04 |
| HXL | Mallet | General, Plastic Surgery | Class 1 | 878.4800 | 2023-07-26 |
| JDW | Pin, Fixation, Threaded | Orthopedic | Class 2 | 888.3040 | 2010-09-22 |
| HTY | Pin, Fixation, Smooth | Orthopedic | Class 2 | 888.3040 | 2010-09-22 |
| HXZ | Cutter, Wire | Orthopedic | Class 1 | 888.4540 | 2013-01-10 |
| GAD | Retractor | General, Plastic Surgery | Class 1 | 878.4800 | 2013-01-10 |
| HXE | Fork | Orthopedic | Class 1 | 888.4540 | 2014-01-24 |
| GAH | Stylet, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2023-07-26 |
| HXI | Passer, Wire, Orthopedic | Orthopedic | Class 1 | 888.4540 | 2008-06-18 |
| HTD | Forceps | General, Plastic Surgery | Class 1 | 878.4800 | 1997-12-04 |
| 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 |
|---|---|---|
| 3004358587 | HURON TOOL & CUTTER GRINDING | Farmingdale, NY, US |
| 3023809973 | RUSUN MEDICAL CO., LTD | Yichun City Jiangxi, CN |
| 3008496217 | DERMATO PLASTICA BEAUTY CO., LTD. | Kaohsiung City, TW |
| 3001614464 | medi-G GMBH | Messkirch Baden-Wurttemberg, DE |
| 3028006458 | ClearPoint Neuro Inc. | Carlsbad, CA, US |
9680619 when referencing this establishment in official correspondence.