FDA Device Registration & Listing · Wolcott, CT, US · Registration 1287329
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 |
|---|---|---|---|---|---|
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Orthopedic | Class 2 | 888.3040 | 2018-11-13 |
| HBE | Drills, Burrs, Trephines & Accessories (Simple, Powered) | Neurology | Class 2 | 882.4310 | 2024-12-30 |
| PIW | Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid | Neurology | Class 2 | 882.1450 | 2022-08-23 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Orthopedic | Class 2 | 888.3040 | 2018-11-13 |
| FTD | Lamp, Surgical | General, Plastic Surgery | Class 2 | 878.4580 | 2018-11-13 |
| KYZ | Syringe, Irrigating (Non Dental) | General Hospital | Class 1 | 880.6960 | 2018-11-13 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2018-11-13 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Orthopedic | Class 2 | 888.3040 | 2018-11-13 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2018-11-13 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Orthopedic | Class 2 | 888.3040 | 2018-11-13 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2018-11-13 |
| QBL | Piston Syringe Lever | General Hospital | Class 2 | 880.5860 | 2020-04-14 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2018-11-13 |
| HXB | Probe | Orthopedic | Class 1 | 888.4540 | 2018-11-13 |
| LXG | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | Clinical Chemistry | Class 1 | 862.2050 | 2020-04-14 |
No US Agent registered (Local establishment).
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3008933393 | Nissha Medical Technologies Limited | Paignton Devon, GB |
| 1317188 | Graphic Controls Acquisition Corp.dba Nissha Medical Technologies | BUFFALO, NY, US |
| 3006891611 | CEA Global Dominicana d.b.a. Nissha Medical Technologies | San Pedro de Macoris, DO |
| 3023164 | LEAD-LOK, INC. d.b.a Nissha Medical Technologies | Sandpoint, ID, US |
| 1721983 | CEA Medical Manufacturing, Inc. | Colorado Springs, CO, 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-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 |
|---|---|---|
| 1219930 | Covidien | North Haven, CT, US |
| 3016660811 | SUBCHONDRAL SOLUTIONS | Costa Mesa, CA, US |
| 1054811 | Sterigenics U.S. LLC | MULBERRY, FL, US |
| 3016851379 | Arthrex Distribution Hub EMEA B.V. | Venlo Limburg, NL |
| 3011989923 | DIAFARMA ECZA DEPOSU VE MEDIKAL DIS TICARET DIS TIC LTD STI | Istanbul, TR |
1287329 when referencing this establishment in official correspondence.