FDA Device Registration & Listing · SOMERSWORTH, NH, US · Registration 1221051
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| KIH | Dispenser, Cement | Orthopedic | Class 1 | 888.4200 | 2018-12-10 |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | General, Plastic Surgery | Class 2 | 878.5000 | 2024-12-05 |
| ORG | Platelet And Plasma Separator For Bone Graft Handling | Hematology | Class 2 | 864.9245 | 2022-06-20 |
| HWQ | Passer | Orthopedic | Class 1 | 888.4540 | 2013-01-07 |
| NPK | Barrier, Synthetic, Intraoral | Dental | Class 2 | 872.3930 | 2017-12-11 |
| SAW | Fluorescence Imaging For Breast Cancer Detection | Unknown | Class 3 | N/A | 2024-12-09 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Orthopedic | Class 2 | 888.3080 | 2018-12-07 |
| MJI | Specimen/Tissue, Identification Orientation | Pathology | Class 1 | 864.3010 | 2013-01-07 |
| FTL | Mesh, Surgical, Polymeric | General, Plastic Surgery | Class 2 | 878.3300 | 2011-06-16 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2020-06-25 |
| HIF | Insufflator, Laparoscopic | Obstetrics/Gynecology | Class 2 | 884.1730 | 2022-07-12 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | Cardiovascular | Class 2 | 870.4210 | 2012-11-08 |
| MAI | Fastener, Fixation, Biodegradable, Soft Tissue | Orthopedic | Class 2 | 888.3030 | 2025-08-18 |
| JXG | Shunt, Central Nervous System And Components | Neurology | Class 2 | 882.5550 | 2017-12-11 |
| HOC | Clip, Iris Retractor | Ophthalmic | Class 1 | 886.4350 | 2022-06-20 |
| FTL | Mesh, Surgical, Polymeric | General, Plastic Surgery | Class 2 | 878.3300 | 2020-01-27 |
| GAP | Suture, Nonabsorbable, Silk | General, Plastic Surgery | Class 2 | 878.5030 | 2010-12-08 |
| GAR | Suture, Nonabsorbable, Synthetic, Polyamide | General, Plastic Surgery | Class 2 | 878.5020 | 2010-12-08 |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | General, Plastic Surgery | Class 2 | 878.5000 | 2010-12-08 |
| GAQ | Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile | General, Plastic Surgery | Class 2 | 878.4495 | 2010-12-08 |
| GAA | Needle, Aspiration And Injection, Disposable | General, Plastic Surgery | Class 1 | 878.4800 | 2013-01-07 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2020-06-25 |
| HRS | Plate, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2020-06-25 |
| ORG | Platelet And Plasma Separator For Bone Graft Handling | Hematology | Class 2 | 864.9245 | 2021-05-07 |
| NQQ | System, Imaging, Optical Coherence Tomography (Oct) | Radiology | Class 2 | 892.1560 | 2022-05-20 |
| FZX | Guide, Surgical, Instrument | General, Plastic Surgery | Class 1 | 878.4800 | 2013-01-07 |
No US Agent registered (Local establishment).
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K072322 | Smith & Nephew, Inc. | ULTRA FAST-FIX AND ULTRA FAST-FIX AB MENISCAL REPAIR SYSTEMS | 2007-09-18 |
| K142269 | Reliance Medical Systems, LLC | Reliance Cervical IBF System | 2015-06-09 |
| K122085 | Omni Surgical, LP Dba Spine360 | STINGRAY CERVICAL CAGE | 2012-10-17 |
| K120275 | Synthes (Usa), LLC | SYNTHES ACIS/VERTEBRAL SPACER CR | 2012-05-25 |
| K220540 | Covidien | ProGrip Self-Gripping Polypropylene Mesh | 2022-09-22 |
| 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 |
|---|---|---|
| 3013186738 | Heraeus Medical LLC | Yardley, PA, US |
| 3007699035 | FORMOSA BIOMEDICAL TECHNOLOGY CORPORATION | Taipei, TW |
| 3000270450 | Synthes GMBH | Selzach Solothurn, CH |
| 3033589330 | Merit Medical Australia Pty Ltd. | Braiside Victoria, AU |
| 9617155 | SUMMIT MEDICAL LTD. | GLOUCESTERSHIRE, GB |
1221051 when referencing this establishment in official correspondence.