FDA Device Registration & Listing · Cedar Knolls, NJ, US · Registration 3015259876
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 |
|---|---|---|---|---|---|
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Orthopedic | Class 2 | 888.3353 | 2019-01-28 |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | Orthopedic | Class 2 | 888.3353 | 2019-01-28 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2019-01-28 |
| HWA | Impactor | Orthopedic | Class 1 | 888.4540 | 2019-01-28 |
| HTS | Knife, Orthopedic | Orthopedic | Class 1 | 888.4540 | 2019-01-28 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Orthopedic | Class 2 | 888.3353 | 2019-02-15 |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | Orthopedic | Class 2 | 888.3353 | 2019-02-15 |
| HWI | Corkscrew | Orthopedic | Class 1 | 888.4540 | 2019-01-28 |
| KTZ | Caliper | Orthopedic | Class 1 | 888.4150 | 2019-01-28 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3560 | 2019-01-28 |
| HXC | Wrench | Orthopedic | Class 1 | 888.4540 | 2022-10-24 |
| NBH | Accessories, Arthroscopic | Orthopedic | Class 1 | 888.1100 | 2019-01-28 |
| HTW | Bit, Drill | Orthopedic | Class 1 | 888.4540 | 2019-01-28 |
| HWT | Template | Orthopedic | Class 1 | 888.4800 | 2019-01-28 |
| HWD | Starter, Bone Screw | Orthopedic | Class 1 | 888.4540 | 2019-01-28 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | Orthopedic | Class 2 | 888.3390 | 2026-06-01 |
| LXH | Orthopedic Manual Surgical Instrument | Orthopedic | Class 1 | 888.4540 | 2019-01-28 |
| HWR | Driver, Prosthesis | Orthopedic | Class 1 | 888.4540 | 2019-01-28 |
| GAD | Retractor | General, Plastic Surgery | Class 1 | 878.4800 | 2020-10-30 |
| HTJ | Gauge, Depth | Orthopedic | Class 1 | 888.4300 | 2019-01-28 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3560 | 2021-03-12 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Orthopedic | Class 2 | 888.3353 | 2024-12-03 |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | Orthopedic | Class 2 | 888.3353 | 2024-12-03 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | Orthopedic | Class 2 | 888.3350 | 2024-12-03 |
| HXK | Holder, Needle; Orthopedic | Orthopedic | Class 1 | 888.4540 | 2019-01-28 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3560 | 2019-01-28 |
| OIY | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | Orthopedic | Class 2 | 888.3560 | 2019-01-28 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3560 | 2022-10-24 |
No US Agent registered (Local establishment).
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3042508254 | b-ONE Ortho Corp. | Fairfield, NJ, US |
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K030151 | Hayes Medical, Inc. | CONSENSUS HIP SYSTEM, UNISYN HIP SYSTEM | 2003-04-10 |
| K153381 | Corin U.S.A. Limited | Corin Metafix Hip Stem | 2016-01-21 |
| K140975 | Lima Corporate S.P.A. | MASTERSL FEMORAL STEM | 2014-06-10 |
| K932222 | Dow Corning Wright | SLT FEMORAL HEAD | 1994-05-27 |
| K910547 | Turnkey Intergration USA, Inc. | FELDMUEHLE CERAMIC HEAD (12/14 X 28MM) | 1991-04-12 |
| 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 |
|---|---|---|
| 3021386586 | LINCOTEK (WUXI) CO., LTD. | Wuxi Jiangsu, CN |
| 3005061536 | SYMMETRY MEDICAL MANUFACTURING INC | CLAYPOOL, IN, US |
| 3007923096 | Changzhou Biomet Medical Devices Co., Ltd. | Changzhou City Jiangsu, CN |
| 3005562917 | BGS Beta-Gamma-Service GmbH & Co KG | Bruchsal Baden-Wurttemberg, DE |
| 1450662 | Isomedix Operations, Inc. | Libertyville, IL, US |
3015259876 when referencing this establishment in official correspondence.