FDA Device Registration & Listing · Horsham, PA, US · Registration 3009996260
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 |
|---|---|---|---|---|---|
| HTN | Washer, Bolt Nut | Orthopedic | Class 2 | 888.3030 | 2020-05-13 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2020-05-13 |
| HWX | Tap, Bone | Orthopedic | Class 1 | 888.4540 | 2020-11-29 |
| HWW | Countersink | Orthopedic | Class 1 | 888.4540 | 2020-05-13 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2020-05-13 |
| HRS | Plate, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2020-05-13 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2024-11-25 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2020-05-13 |
| LXH | Orthopedic Manual Surgical Instrument | Orthopedic | Class 1 | 888.4540 | 2013-02-28 |
| HWT | Template | Orthopedic | Class 1 | 888.4800 | 2020-05-13 |
| HRS | Plate, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2020-05-13 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2020-05-13 |
| HXX | Screwdriver | Orthopedic | Class 1 | 888.4540 | 2020-05-13 |
| HXW | Bender | Orthopedic | Class 1 | 888.4540 | 2020-05-13 |
| HTO | Reamer | Orthopedic | Class 1 | 888.4540 | 2020-05-13 |
| FSM | Tray, Surgical, Instrument | General, Plastic Surgery | Class 1 | 878.4800 | 2021-03-09 |
| HSB | Rod, Fixation, Intramedullary And Accessories | Orthopedic | Class 2 | 888.3020 | 2022-11-23 |
| HXI | Passer, Wire, Orthopedic | Orthopedic | Class 1 | 888.4540 | 2020-05-13 |
| HTW | Bit, Drill | Orthopedic | Class 1 | 888.4540 | 2020-05-13 |
| HSB | Rod, Fixation, Intramedullary And Accessories | Orthopedic | Class 2 | 888.3020 | 2021-01-26 |
| KDD | Kit, Surgical Instrument, Disposable | General, Plastic Surgery | Class 1 | 878.4800 | 2020-05-13 |
No official correspondent registered.
No US Agent registered (Local establishment).
| 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-0034-2022 | Flower Orthopedics Corporation | 2 | Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201 |
| 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. |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3007923096 | Changzhou Biomet Medical Devices Co., Ltd. | Changzhou City Jiangsu, CN |
| 3009417901 | SYNTHES GMBH | Zuchwil Solothurn, CH |
| 3006783837 | STRUCTURE MEDICAL, LLC. | Naples, FL, US |
| 3003604053 | SMITH & NEPHEW INC. | ANDOVER, MA, US |
| 3008870565 | Implant Logistics / AMS Micromedical | Sparta, WI, US |
3009996260 when referencing this establishment in official correspondence.