FDA Device Registration & Listing · Rohrmoser San Jose, CR · Registration 3027242374
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| HTN | Washer, Bolt Nut | Orthopedic | Class 2 | 888.3030 | 2023-04-20 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Orthopedic | Class 2 | 888.3040 | 2023-04-20 |
| MAI | Fastener, Fixation, Biodegradable, Soft Tissue | Orthopedic | Class 2 | 888.3030 | 2023-04-20 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2023-04-20 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Orthopedic | Class 2 | 888.3040 | 2023-04-20 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2023-04-20 |
| HRS | Plate, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2023-04-20 |
| FMF | Syringe, Piston | General Hospital | Class 2 | 880.5860 | 2023-04-20 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Orthopedic | Class 2 | 888.3040 | 2023-04-20 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2023-04-20 |
| MAI | Fastener, Fixation, Biodegradable, Soft Tissue | Orthopedic | Class 2 | 888.3030 | 2023-04-20 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2023-04-20 |
| MAI | Fastener, Fixation, Biodegradable, Soft Tissue | Orthopedic | Class 2 | 888.3030 | 2023-04-20 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Orthopedic | Class 2 | 888.3040 | 2023-04-20 |
| HRX | Arthroscope | Orthopedic | Class 2 | 888.1100 | 2023-04-20 |
| HXD | Clamp | General, Plastic Surgery | Class 1 | 878.4800 | 2025-07-24 |
| HRX | Arthroscope | Orthopedic | Class 2 | 888.1100 | 2023-04-20 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Orthopedic | Class 2 | 888.3040 | 2023-04-20 |
| JDR | Staple, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2023-04-20 |
| MAI | Fastener, Fixation, Biodegradable, Soft Tissue | Orthopedic | Class 2 | 888.3030 | 2023-04-20 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2023-04-20 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2023-04-20 |
| MAI | Fastener, Fixation, Biodegradable, Soft Tissue | Orthopedic | Class 2 | 888.3030 | 2023-04-20 |
| HTN | Washer, Bolt Nut | Orthopedic | Class 2 | 888.3030 | 2023-04-20 |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | General, Plastic Surgery | Class 2 | 878.5000 | 2023-04-20 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Orthopedic | Class 2 | 888.3040 | 2023-04-20 |
| HRS | Plate, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2023-04-20 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2023-04-20 |
| HTN | Washer, Bolt Nut | Orthopedic | Class 2 | 888.3030 | 2023-04-20 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2023-04-20 |
| HTN | Washer, Bolt Nut | Orthopedic | Class 2 | 888.3030 | 2023-04-20 |
| MAI | Fastener, Fixation, Biodegradable, Soft Tissue | Orthopedic | Class 2 | 888.3030 | 2023-04-20 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2023-04-20 |
| FYD | Apparatus, Exhaust, Surgical | General, Plastic Surgery | Class 2 | 878.5070 | 2023-04-20 |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | General, Plastic Surgery | Class 2 | 878.5000 | 2025-07-24 |
| HRS | Plate, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2025-07-24 |
| CAH | Filter, Bacterial, Breathing-Circuit | Anesthesiology | Class 2 | 868.5260 | 2023-04-20 |
| HRX | Arthroscope | Orthopedic | Class 2 | 888.1100 | 2023-04-20 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2023-04-20 |
| HTJ | Gauge, Depth | Orthopedic | Class 1 | 888.4300 | 2025-07-24 |
| HTY | Pin, Fixation, Smooth | Orthopedic | Class 2 | 888.3040 | 2023-04-20 |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | General, Plastic Surgery | Class 2 | 878.5000 | 2023-04-20 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Orthopedic | Class 2 | 888.3040 | 2023-04-20 |
| MAI | Fastener, Fixation, Biodegradable, Soft Tissue | Orthopedic | Class 2 | 888.3030 | 2023-04-20 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2023-04-20 |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | General, Plastic Surgery | Class 2 | 878.5000 | 2023-04-20 |
| HRS | Plate, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2023-04-20 |
| GAP | Suture, Nonabsorbable, Silk | General, Plastic Surgery | Class 2 | 878.5030 | 2023-04-20 |
| HRS | Plate, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2023-04-20 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2023-04-20 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2023-04-20 |
| HRS | Plate, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2023-04-20 |
| MAI | Fastener, Fixation, Biodegradable, Soft Tissue | Orthopedic | Class 2 | 888.3030 | 2023-04-20 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Orthopedic | Class 2 | 888.3040 | 2023-04-20 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Orthopedic | Class 2 | 888.3040 | 2023-04-20 |
| HTD | Forceps | General, Plastic Surgery | Class 1 | 878.4800 | 2025-07-24 |
| HTN | Washer, Bolt Nut | Orthopedic | Class 2 | 888.3030 | 2025-07-24 |
| HWE | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | General, Plastic Surgery | Class 1 | 878.4820 | 2025-07-24 |
| JDR | Staple, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2023-04-20 |
| HXJ | Staple Driver | Orthopedic | Class 1 | 888.4540 | 2023-04-20 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2023-04-20 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2023-04-20 |
| MAI | Fastener, Fixation, Biodegradable, Soft Tissue | Orthopedic | Class 2 | 888.3030 | 2023-04-20 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Orthopedic | Class 2 | 888.3040 | 2023-04-20 |
| KQM | Camera, Surgical And Accessories | General, Plastic Surgery | Class 1 | 878.4160 | 2025-07-24 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Orthopedic | Class 2 | 888.3040 | 2023-04-20 |
| MAI | Fastener, Fixation, Biodegradable, Soft Tissue | Orthopedic | Class 2 | 888.3030 | 2023-04-20 |
| HRS | Plate, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2025-07-24 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2025-07-24 |
| JDR | Staple, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2025-07-24 |
No official correspondent registered.
| 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 |
|---|---|---|
| 3007923096 | Changzhou Biomet Medical Devices Co., Ltd. | Changzhou City Jiangsu, CN |
| 3009417901 | SYNTHES GMBH | Zuchwil Solothurn, CH |
| 3006783837 | STRUCTURE MEDICAL, LLC. | Naples, FL, US |
| 3003604053 | SMITH & NEPHEW INC. | ANDOVER, MA, US |
| 3008870565 | Implant Logistics / AMS Micromedical | Sparta, WI, US |
3027242374 when referencing this establishment in official correspondence.