Tasmin R 8°
The basic shape of the TASMIN R devices is a hollow structural frame having a rounded, tapered leading face. The upper and lower aspects of the implant are open with peaked teeth that…
The basic shape of the TASMIN R devices is a hollow structural frame having a rounded, tapered leading face. The upper and lower aspects of the implant are open with peaked teeth that assist in anchoring and seating the implant between the vertebral bodies. There are lateral fenestrations for bony in-growth. the device is avaiable in a variety of sizes and angulations thereby enabling the surgeon to choose the size best suited to the individual pathology and anatomical condition.
Who Else Makes It
Concentrated in Shanghai (1), Jiangsu (1), Shandong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
Record
| Listed by | Signus Medizintechnik Gmbh, Germany |
|---|---|
| FDA product code | MQP |
| Device type | Spinal Vertebral Body Replacement Device |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K123758 |
| Record published | 2015-09-24 |
| Record revised | 2023-09-29 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 0 to 35 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Lumbar cage, angled | 11x9x24mm | In distribution |
| Lumbar cage, angled | 9x9x24mm | In distribution |
| Lumbar cage, angled | 10x9x24mm | In distribution |
| Lumbar cage, angled | 13x9x28mm | In distribution |
| Lumbar cage, angled | 10x9x28mm | In distribution |
| Lumbar cage, angled | 9x9x28mm | In distribution |
| Lumbar cage, angled | 16x9x24mm | In distribution |
| Lumbar cage, angled | 15x9x24mm | In distribution |
| Lumbar cage, angled | 11x9x28mm | In distribution |
| Lumbar cage, angled | 16x9x28mm | In distribution |
| Lumbar cage, angled | 13x9x24mm | In distribution |
| Lumbar cage, angled | 14x9x28mm | In distribution |
| Lumbar cage, angled | 12x9x28mm | In distribution |
| Lumbar cage, angled | 12x9x24mm | In distribution |
| Lumbar cage, angled | 14x9x24mm | In distribution |
| Lumbar cage, angled | 15x9x28mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CoRoent | Nuvasive, Inc. | 1,514 |
| Capri™ Corpectomy Cage System | VB Spine LLC | 1,509 |
| Aleutian® Interbody Systems | VB Spine LLC | 1,189 |
| Fortify | Globus Medical, Inc. | 866 |
| Matrixx System | Nexxt Spine LLC | 748 |
| Ascend | Alphatec Spine, Inc. | 555 |
| Zavation VBR Trial | Zavation | 548 |
| Verte-Stack® Spinal System | Medtronic Sofamor Danek, Inc. | 484 |
| Timberline® Lateral Interbody Fusion System | Biomet Spine | 470 |
| Timberline Lateral Fusion System | Biomet Spine | 459 |
| Novel | Alphatec Spine, Inc. | 447 |
| Hawkeye™ Vertebral Body Replacement (VBR) | Choice Spine, LP | 368 |
Showing 12 of 683. All products under Spinal Vertebral Body Replacement Device
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K123758 | 2014-01-14 |
| K081332 | 2008-06-10 |
| K080349 | 2008-03-10 |
| K061082 | 2006-12-18 |
| K052533 | 2005-11-03 |
| K051659 | 2005-07-13 |
| K043316 | 2005-02-07 |
| K041888 | 2004-08-10 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.