FDA Device Registration & Listing · Houston, TX, US · Registration 3007420745
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| HXX | Screwdriver | Orthopedic | Class 1 | 888.4540 | 2017-07-27 |
| PHX | Shoulder Prosthesis, Reverse Configuration | Orthopedic | Class 2 | 888.3660 | 2021-12-01 |
| HRS | Plate, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2017-11-29 |
| HWT | Template | Orthopedic | Class 1 | 888.4800 | 2017-07-27 |
| KWD | Prosthesis, Toe, Hemi-, Phalangeal | Orthopedic | Class 2 | 888.3730 | 2008-11-12 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2014-01-07 |
| HRS | Plate, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2014-01-07 |
| HTE | Elevator | General, Plastic Surgery | Class 1 | 878.4800 | 2018-03-20 |
| HXD | Clamp | General, Plastic Surgery | Class 1 | 878.4800 | 2017-07-27 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2016-06-13 |
| JDR | Staple, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2026-02-05 |
| HTW | Bit, Drill | Orthopedic | Class 1 | 888.4540 | 2017-07-27 |
| PHX | Shoulder Prosthesis, Reverse Configuration | Orthopedic | Class 2 | 888.3660 | 2021-12-01 |
| HRS | Plate, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2019-09-13 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2019-09-13 |
| GAD | Retractor | General, Plastic Surgery | Class 1 | 878.4800 | 2017-07-27 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | Orthopedic | Class 2 | 888.3030 | 2023-08-04 |
| LRP | Tray, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2017-07-27 |
| LRY | Punch, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2026-02-05 |
| HSB | Rod, Fixation, Intramedullary And Accessories | Orthopedic | Class 2 | 888.3020 | 2025-11-19 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2025-06-10 |
| HTN | Washer, Bolt Nut | Orthopedic | Class 2 | 888.3030 | 2025-06-10 |
| HTY | Pin, Fixation, Smooth | Orthopedic | Class 2 | 888.3040 | 2013-01-02 |
| HTJ | Gauge, Depth | Orthopedic | Class 1 | 888.4300 | 2017-07-27 |
| HXW | Bender | Orthopedic | Class 1 | 888.4540 | 2017-07-27 |
| MDM | Instrument, Manual, Surgical, General Use | General, Plastic Surgery | Class 1 | 878.4800 | 2017-07-27 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2008-11-12 |
| PHX | Shoulder Prosthesis, Reverse Configuration | Orthopedic | Class 2 | 888.3660 | 2021-12-01 |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | Orthopedic | Class 2 | 888.3660 | 2021-12-01 |
| FSM | Tray, Surgical, Instrument | General, Plastic Surgery | Class 1 | 878.4800 | 2023-08-22 |
| JDR | Staple, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2017-04-25 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2021-12-01 |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | Orthopedic | Class 2 | 888.3660 | 2021-12-01 |
| PHX | Shoulder Prosthesis, Reverse Configuration | Orthopedic | Class 2 | 888.3660 | 2021-12-01 |
| HTQ | Broach | Orthopedic | Class 1 | 888.4540 | 2017-07-27 |
| KDD | Kit, Surgical Instrument, Disposable | General, Plastic Surgery | Class 1 | 878.4800 | 2025-06-10 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3560 | 2021-12-01 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Orthopedic | Class 2 | 888.3040 | 2025-06-10 |
| HWW | Countersink | Orthopedic | Class 1 | 888.4540 | 2017-05-05 |
| FZX | Guide, Surgical, Instrument | General, Plastic Surgery | Class 1 | 878.4800 | 2017-07-27 |
| HSB | Rod, Fixation, Intramedullary And Accessories | Orthopedic | Class 2 | 888.3020 | 2025-06-10 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Orthopedic | Class 2 | 888.3040 | 2026-02-05 |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | General, Plastic Surgery | Class 2 | 878.5000 | 2026-02-05 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2026-02-05 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2014-01-07 |
| HRS | Plate, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2014-01-07 |
| HRS | Plate, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2016-06-13 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2016-06-13 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2013-01-02 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Orthopedic | Class 2 | 888.3358 | 2021-12-01 |
| OQG | Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | Orthopedic | Class 2 | 888.3358 | 2021-12-01 |
| JDS | Nail, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2025-06-10 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2025-06-10 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2012-01-10 |
| LXH | Orthopedic Manual Surgical Instrument | Orthopedic | Class 1 | 888.4540 | 2017-07-27 |
| NTG | Prosthesis, Ankle, Uncemented, Non-Constrained | Unknown | Class 3 | N/A | 2023-11-05 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | Orthopedic | Class 2 | 888.3030 | 2023-08-04 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2013-01-02 |
| HRS | Plate, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2013-01-02 |
| HRS | Plate, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2022-04-06 |
| HTN | Washer, Bolt Nut | Orthopedic | Class 2 | 888.3030 | 2022-04-06 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2022-04-06 |
| NDG | Washer, Bolt, Nut, Non-Spinal, Metallic | Orthopedic | Class 2 | 888.3030 | 2022-04-06 |
| HWB | Extractor | Orthopedic | Class 1 | 888.4540 | 2017-07-27 |
| JDR | Staple, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2025-06-10 |
No US Agent registered (Local establishment).
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K141345 | Tornier S.A.S. | AEQUALIS FX2 | 2014-11-18 |
| 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 |
| 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 |
|---|---|---|
| 1417592 | MEDLINE INDUSTRIES, LP - Northfield | Northfield, IL, US |
| 3009959868 | Ferry Machine Corporation | Little Ferry, NJ, US |
| 8010916 | Kammerer Medical Systems GmbH & Co. KG | Stockach Baden-Wurttemberg, DE |
| 3007689689 | ELOS MEDTECH PINOL A/S | Goerloese Hovedstaden, DK |
| 1038671 | EXACTECH, INC. | GAINESVILLE, FL, US |
3007420745 when referencing this establishment in official correspondence.