Zuma-L™
Zuma-L Implant, 55mm x 18mm x 14mm, 0 Deg
3manufacturers in China registered for this device type
56catalogue numbers in this listing
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 | Seaspine Orthopedics Corporation, United States |
|---|---|
| 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 |
| 510(k) | K082926 |
| Record published | 2015-09-24 |
| Record revised | 2025-11-20 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Distribution end date | 2016-09-02 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 56-5614 | 55mm x 18mm x 14mm, 0 Deg | In distribution |
| 56-4514 | 45mm x 18mm x 14mm, 8 Deg | In distribution |
| 56-5110 | 50mm x 18mm x 10mm, 0 Deg | In distribution |
| 56-8030 | 6.5 x 30mm | In distribution |
| 56-5014 | 50mm x 18mm x 14mm, 8 Deg | In distribution |
| 56-9012 | 12mm | In distribution |
| 56-5010 | 50mm x 18mm x 10mm, 8 Deg | In distribution |
| 95-6145 | Height Trial, 45mm x 18mm, 0 Deg | In distribution |
| 56-7030 | 5.5 x 30mm | In distribution |
| 56-5108 | 50mm x 18mm x 8mm, 0 Deg | In distribution |
| 95-6040 | Height Trial, 45 mm x 08 mm, 8° | In distribution |
| 95-6545 | N/A | In distribution |
| 95-6533 | Height Trial, 45mm x 10mm, 0 ° , L4-L5 | In distribution |
| 95-6558 | Height Trial, 45mm x 14mm, 8° , L4-L5 | In distribution |
| 56-7040 | 5.5 x 40mm | In distribution |
| 56-4614 | 45mm x 18mm x 14mm, 0 Deg | In distribution |
| 56-5012 | 50mm x 18mm x 12mm, 8 Deg | In distribution |
| 56-5610 | 55mm x 18mm x 10mm, 0 Deg | In distribution |
| 56-5508 | 55mm x 18mm x 8mm, 8 Deg | In distribution |
| 95-6143 | Height Trial, 45mm x 14mm, 0 Deg | In distribution |
| 95-6537 | Height Trial, 45mm x 18mm, 0 ° , L4-L5 | In distribution |
| 56-8060 | 6.5 x 60mm | In distribution |
| 95-6041 | Height Trial, 45 mm x 10 mm, 8° | In distribution |
| 56-5114 | 50mm x 18mm x 14mm, 0 Deg | In distribution |
| 56-4610 | 45mm x 18mm x 10mm, 0 Deg | In distribution |
| 95-6045 | Height Trial, 45 mm x 18 mm, 8° | In distribution |
| 95-6142 | Height Trial, 45mm x 12mm, 0 Deg | In distribution |
| 56-7035 | 5.5 x 35mm | In distribution |
| 95-6141 | Height Trial, 45mm x 10mm, 0 Deg | In distribution |
| 95-6535 | Height Trial, 45mm x 14mm, 0 ° , L4-L5 | In distribution |
| 56-5612 | 55mm x 18mm x 12mm, 0 Deg | In distribution |
| 95-6043 | Height Trial, 45 mm x 14 mm, 8° | In distribution |
| 95-6144 | Height Trial, 45mm x 16mm, 0 Deg | In distribution |
| 95-6557 | Height Trial, 45mm x 12mm, 8° , L4-L5 | In distribution |
| 95-6556 | Height Trial, 45mm x 10mm, 8° , L4-L5 | In distribution |
| 56-8050 | 6.5 x 50mm | In distribution |
| 95-6555 | Height Trial, 45mm x 8mm, 8° , L4-L5 | In distribution |
| 95-6548 | N/A | In distribution |
| 56-5512 | 55mm x 18mm x 12mm, 8 Deg | In distribution |
| 56-8040 | 6.5 x 40mm | In distribution |
| 56-7025 | 5.5 x 25mm | Withdrawn |
| 56-9018 | 18mm | Withdrawn |
| 56-8025 | 6.5 x 25mm | Withdrawn |
| 56-5616 | 55mm x 18mm x 16mm, 0 Deg | Withdrawn |
| 56-4114 | 40mm x 18mm x 14mm, 0 Deg | Withdrawn |
| 56-5116 | 50mm x 18mm x 16mm, 0 Deg | Withdrawn |
| 56-4112 | 40mm x 18mm x 12mm, 0 Deg | Withdrawn |
| 56-4516 | 45mm x 18mm x 16mm, 8 Deg | Withdrawn |
| 56-7060 | 5.5 x 60mm | Withdrawn |
| 56-4518 | 45mm x 18mm x 18mm, 8 Deg | Withdrawn |
| 56-4014 | 40mm x 18mm x 14mm, 8 Deg | Withdrawn |
| 56-4116 | 40mm x 18mm x 16mm, 0 Deg | Withdrawn |
| 56-8045 | 6.5 x 45mm | Withdrawn |
| 56-5016 | 50mm x 18mm x 16mm, 8 Deg | Withdrawn |
| 56-9016 | 16mm | Withdrawn |
| 56-5618 | 55mm x 18mm x 18mm, 0 Deg | Withdrawn |
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
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.