Zuma-L™
Zuma-L Implant, 55mm x 18mm x 18mm, 8 Deg
3manufacturers in China registered for this device type
43catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Shandong (2), Jiangsu (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
Record
| Listed by | Seaspine Orthopedics Corporation, United States |
|---|---|
| FDA product code | OVD |
| Device type | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| 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 |
|---|---|---|
| 56-4508 | 45mm x 18mm x 8mm, 8 Deg | In distribution |
| 56-7045 | 5.5 x 45mm | In distribution |
| 95-6536 | Height Trial, 45mm x 16mm, 0 ° , L4-L5 | In distribution |
| 95-6559 | Height Trial, 45mm x 16mm, 8° , L4-L5 | In distribution |
| 56-7050 | 5.5 x 50mm | In distribution |
| 56-9014 | 14mm | In distribution |
| 56-4510 | 45mm x 18mm x 10mm, 8 Deg | In distribution |
| 95-6042 | Height Trial, 45 mm x 12 mm, 8° | In distribution |
| 95-6560 | Height Trial, 45mm x 18mm, 8° , L4-L5 | In distribution |
| 56-5514 | 55mm x 18mm x 14mm, 8 Deg | In distribution |
| 56-5008 | 50mm x 18mm x 8mm, 8 Deg | In distribution |
| 56-8035 | 6.5 x 35mm | In distribution |
| 56-9008 | 8mm | In distribution |
| 95-6140 | Height Trial, 45mm x 08mm, 0 Deg | In distribution |
| 95-6038 | N/A | In distribution |
| 56-9010 | 10mm | In distribution |
| 95-6534 | Height Trial, 45mm x 12mm, 0 ° , L4-L5 | In distribution |
| 56-8055 | 6.5 x 55mm | In distribution |
| 56-5510 | 55mm x 18mm x 10mm, 8 Deg | In distribution |
| 56-4512 | 45mm x 18mm x 12mm, 8 Deg | In distribution |
| 56-7055 | 5.5 x 55mm | In distribution |
| 95-6044 | Height Trial, 45 mm x 16 mm, 8° | In distribution |
| 56-5608 | 55mm x 18mm x 8mm, 0 Deg | In distribution |
| 56-5112 | 50mm x 18mm x 12mm, 0 Deg | In distribution |
| 56-4608 | 45mm x 18mm x 8mm, 0 Deg | In distribution |
| 56-4612 | 45mm x 18mm x 12mm, 0 Deg | In distribution |
| 95-6532 | Height Trial, 45mm x 8mm, 0 ° , L4-L5 | In distribution |
| 56-4008 | 40mm x 18mm x 8mm, 8 Deg | Withdrawn |
| 56-4110 | 40mm x 18mm x 10mm, 0 Deg | Withdrawn |
| 56-5518 | 55mm x 18mm x 18mm, 8 Deg | Withdrawn |
| 56-4108 | 40mm x 18mm x 8mm, 0 Deg | Withdrawn |
| 56-4012 | 40mm x 18mm x 12mm, 8 Deg | Withdrawn |
| 56-5118 | 50mm x 18mm x 18mm, 0 Deg | Withdrawn |
| 56-4010 | 40mm x 18mm x 10mm, 8 Deg | Withdrawn |
| 56-7065 | 5.5 x 65mm | Withdrawn |
| 56-4618 | 45mm x 18mm x 18mm, 0 Deg | Withdrawn |
| 56-4118 | 40mm x 18mm x 18mm, 0 Deg | Withdrawn |
| 56-5018 | 50mm x 18mm x 18mm, 8 Deg | Withdrawn |
| 56-4016 | 40mm x 18mm x 16mm, 8 Deg | Withdrawn |
| 56-4018 | 40mm x 18mm x 18mm, 8 Deg | Withdrawn |
| 56-5516 | 55mm x 18mm x 16mm, 8 Deg | Withdrawn |
| 56-8065 | 6.5 x 65mm | Withdrawn |
| 56-4616 | 45mm x 18mm x 16mm, 0 Deg | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sirion | Astura Medical | 1,465 |
| IdentiTi | Alphatec Spine, Inc. | 1,372 |
| EL Capitan | Astura Medical | 1,205 |
| Zavation | Zavation | 1,157 |
| Brigade | Nuvasive, Inc. | 1,005 |
| Solar™ Interbody Fusion System | Degen Medical | 899 |
| Zavation F3D Corpectomy | Zavation | 730 |
| ROI-A | Ldr Spine USA | 552 |
| Avenue L | Ldr Spine USA | 524 |
| Transcend Nanotec | Alphatec Spine, Inc. | 485 |
| Endoskeleton® TL Hyperlordotic nanoLOCK® Surface Technology | Titan Spine, LLC | 462 |
| Base | Nuvasive, Inc. | 462 |
Showing 12 of 241. All products under Intervertebral Fusion Device With Integrated Fixation, Lumbar
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K173606 | 2018-04-13 |
| K162351 | 2016-12-01 |
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.