FDA Device Registration & Listing · PONTE VEDRA, FL, US · Registration 3011623994
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| HRS | Plate, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2015-10-06 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2015-10-06 |
| HWM | Osteotome | General, Plastic Surgery | Class 1 | 878.4800 | 2021-12-02 |
| HWN | Instrument, Compression | Orthopedic | Class 1 | 888.4540 | 2022-06-03 |
| HTQ | Broach | Orthopedic | Class 1 | 888.4540 | 2025-07-22 |
| JDR | Staple, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2024-10-21 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2024-10-21 |
| HRS | Plate, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2025-09-29 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2025-09-29 |
| JDR | Staple, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2025-09-29 |
| HXG | Tamp | Orthopedic | Class 1 | 888.4540 | 2025-03-20 |
| HWE | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | General, Plastic Surgery | Class 1 | 878.4820 | 2016-07-25 |
| HXX | Screwdriver | Orthopedic | Class 1 | 888.4540 | 2016-12-08 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2023-08-18 |
| HWX | Tap, Bone | Orthopedic | Class 1 | 888.4540 | 2023-08-18 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2020-02-26 |
| HRS | Plate, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2020-02-26 |
| FZX | Guide, Surgical, Instrument | General, Plastic Surgery | Class 1 | 878.4800 | 2022-06-03 |
| HTJ | Gauge, Depth | Orthopedic | Class 1 | 888.4300 | 2021-09-20 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2026-04-01 |
| HWW | Countersink | Orthopedic | Class 1 | 888.4540 | 2021-09-20 |
| GFA | Blade, Saw, General & Plastic Surgery, Surgical | General, Plastic Surgery | Class 1 | 878.4820 | 2025-02-24 |
| HTW | Bit, Drill | Orthopedic | Class 1 | 888.4540 | 2016-03-01 |
| HRS | Plate, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2019-06-10 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2019-06-10 |
| JDR | Staple, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2023-09-21 |
| PBF | Orthopaedic Surgical Planning And Instrument Guides | Orthopedic | Class 2 | 888.3030 | 2023-08-09 |
| JDR | Staple, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2023-01-06 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2021-12-02 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2024-10-21 |
| HRS | Plate, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2020-07-16 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2020-07-16 |
| LXH | Orthopedic Manual Surgical Instrument | Orthopedic | Class 1 | 888.4540 | 2015-10-06 |
| FSM | Tray, Surgical, Instrument | General, Plastic Surgery | Class 1 | 878.4800 | 2018-08-23 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2019-06-20 |
| GDX | Scalpel, One-Piece | General, Plastic Surgery | Class 1 | 878.4800 | 2021-12-02 |
| HRS | Plate, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2024-04-24 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2024-04-24 |
| LMD | System, Digital Image Communications, Radiological | Radiology | Class 1 | 892.2020 | 2026-04-24 |
| HXW | Bender | Orthopedic | Class 1 | 888.4540 | 2022-06-03 |
| FZO | Chisel, Surgical, Manual | General, Plastic Surgery | Class 1 | 878.4800 | 2022-08-24 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2018-05-07 |
| HRS | Plate, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2018-05-07 |
No US Agent registered (Local establishment).
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K042598 | Zimmer, Inc. | PERIARTICULAR LOCKING PLATES AND SCREWS, 2357 AND 2359 SERIES | 2004-10-29 |
| K190842 | Jiangsu Trauhui Medical Instrument Co., Ltd. | Comus Locking Plate systems | 2020-02-03 |
| K130510 | Arthrex, Inc. | ARTHREX COMPRESSION PLATES | 2013-09-25 |
| K202803 | Newclip Technics | Activmotion S DTO | 2021-12-16 |
| K062348 | Medtronic Neurosurgery | TIMESH SELF DRILLING SCREW | 2006-09-08 |
| 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 |
|---|---|---|
| 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 |
| 3017609305 | PRIMEMED INC. | Sungnam-city Gyeonggi, KR |
| 3015410662 | Jabil Inc. (Wilson Drive) | W Chester, PA, US |
3011623994 when referencing this establishment in official correspondence.