FDA Device Registration & Listing · Arlington, TX, US · Registration 3010531069
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| PMP | Dorsal Root Ganglion Stimulator For Pain Relief | Unknown | Class 3 | N/A | 2023-12-13 |
| KDD | Kit, Surgical Instrument, Disposable | General, Plastic Surgery | Class 1 | 878.4800 | 2022-06-09 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Orthopedic | Class 2 | 888.3040 | 2021-11-30 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2015-01-20 |
| HTN | Washer, Bolt Nut | Orthopedic | Class 2 | 888.3030 | 2015-01-20 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Orthopedic | Class 2 | 888.3358 | 2015-01-20 |
| OQG | Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | Orthopedic | Class 2 | 888.3358 | 2015-01-20 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Orthopedic | Class 2 | 888.3353 | 2015-01-20 |
| OQI | Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented | Orthopedic | Class 2 | 888.3353 | 2015-01-20 |
| FPA | Set, Administration, Intravascular | General Hospital | Class 2 | 880.5440 | 2020-11-05 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | Clinical Chemistry | Class 2 | 862.1675 | 2020-11-05 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2024-11-04 |
| FPA | Set, Administration, Intravascular | General Hospital | Class 2 | 880.5440 | 2020-11-05 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | Clinical Chemistry | Class 2 | 862.1675 | 2020-11-05 |
| MUU | System, Suction, Lipoplasty | General, Plastic Surgery | Class 2 | 878.5040 | 2022-01-17 |
| FTR | Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled | General, Plastic Surgery | Class 3 | 878.3540 | 2015-01-20 |
| FQH | Lavage, Jet | General Hospital | Class 2 | 880.5475 | 2025-06-18 |
| KWD | Prosthesis, Toe, Hemi-, Phalangeal | Orthopedic | Class 2 | 888.3730 | 2012-10-15 |
| FWM | Prosthesis, Breast, Inflatable, Internal, Saline | General, Plastic Surgery | Class 3 | 878.3530 | 2015-01-20 |
| OIY | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | Orthopedic | Class 2 | 888.3560 | 2015-01-20 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3560 | 2015-01-20 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Orthopedic | Class 2 | 888.3358 | 2015-01-20 |
| DWS | Instruments, Surgical, Cardiovascular | Cardiovascular | Class 1 | 870.4500 | 2022-12-08 |
| QKL | Lipoaspirate Washing System For Aesthetic Body Contouring | General, Plastic Surgery | Class 2 | 878.5040 | 2023-08-18 |
| MHY | Stimulator, Electrical, Implanted, For Parkinsonian Tremor | Unknown | Class 3 | N/A | 2023-12-13 |
| NHL | Stimulator, Electrical, Implanted, For Parkinsonian Symptoms | Unknown | Class 3 | N/A | 2023-12-13 |
| PJS | Stimulator, Electrical, Implanted, For Essential Tremor | Unknown | Class 3 | N/A | 2023-12-13 |
No official correspondent registered.
No US Agent registered (Local establishment).
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3013023969 | PRO-TECH Design & Mfg, Inc. | Santa Fe Springs, CA, US |
| 2183319 | SURGICAL TECHNOLOGIES, INC. | ST. PAUL, MN, US |
| 2032521 | PRO-TECH DESIGN & MFG., INC. | SANTA FE SPRINGS, CA, US |
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K193295 | Parcus Medical, LLC | Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor | 2020-01-23 |
| K193606 | Conmed Corporation | Y-Knot OneStep Anchor | 2020-01-22 |
| K984200 | R. Thomas Grotz, M.D., Inc. | STABILIZER SOFT TISSUE ANCHOR, 5 AND 8MM; ANCHOR INSERTER, 5 AND 8MM; STABILIZER DRILL, 5 AND 8MM, NONSTERILE; STABILIZE | 1999-01-21 |
| K171060 | Riverpoint Medical | OrthoButton AL | 2017-06-02 |
| K231867 | Paragon 28, Inc. | Grappler Suture Anchor System | 2023-08-21 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-2367-2024 | Abbott Medical | 3 | Abbott Proclaim DRG Implantable Pulse Generator, REF 3664, Sterile EO, Rx Only |
| 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 |
|---|---|---|
| 3008607695 | EXTRUMED, INC. | Corona, CA, US |
| 1627487 | Abbott Medical | PLANO, TX, US |
| 3038429246 | EPTAM PRECISION MOLDING MA (A DIVISION OF EPTAM PRECISION) | Lancaster, MA, US |
| 3009627506 | ACCUMOLD LLC | Ankeny, IA, US |
| 3019807891 | CENTERPIECE S. DE R.L DE C.V (sterilization site) | Tijuana Baja California, MX |
3010531069 when referencing this establishment in official correspondence.