Zuma™
Zuma-LP Implant, 32mm x 25mm x 18mm, 12 Deg
3manufacturers in China registered for this device type
29catalogue 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 |
|---|---|---|
| 55-2716 | 26mm x 24mm x 16mm, 12 Deg | In distribution |
| 55-3518 | 32mm x 25mm x 18mm, 12 Deg | In distribution |
| 95-5268 | Trial, 38mm x 26mm x 18mm, 8 Deg | In distribution |
| 95-5264 | Trial, 38mm x 26mm x 14mm, 8 Deg | In distribution |
| 55-6112 | 12mm | In distribution |
| 95-5286 | Trial, 38mm x 26mm x 16mm, 12 Deg | In distribution |
| 55-3922 | 38mm x 26mm x 22mm, 12 Deg | In distribution |
| 55-3918 | 38mm x 26mm x 18mm, 12 Deg | In distribution |
| 55-3310 | 32mm x 25mm x 10mm, 12 Deg | In distribution |
| 55-3412 | 32mm x 25mm x 12mm, 8 Deg | In distribution |
| 95-5260 | Trial, 38mm x 26mm x 10mm, 8 Deg | In distribution |
| 95-5242 | Trial, 26mm x 24mm x 12mm, 12 Deg | In distribution |
| 55-3912 | 38mm x 26mm x 12mm, 12 Deg | In distribution |
| 55-6114 | 14mm | In distribution |
| 95-5228 | Trial, 32mm x 25mm x 12mm, 12 Deg | In distribution |
| 55-3312 | 32mm x 25mm x 12mm, 12 Deg | In distribution |
| 55-2722 | 26mm x 24mm x 22mm, 12 deg | In distribution |
| 55-2718 | 26mm x 24mm x 18mm, 12 Deg | In distribution |
| 55-3416 | 32mm x 25mm x 16mm, 8 Deg | In distribution |
| 95-5230 | Trial, 32mm x 25mm x 14mm, 12 Deg | In distribution |
| 55-6110 | 10mm | In distribution |
| 55-7025 | Ø6.0mm x 25mm | In distribution |
| 95-5234 | Trial, 32mm x 25mm x 18mm, 12 Deg | In distribution |
| 55-3516 | 32mm x 25mm x 16mm, 12 Deg | In distribution |
| 55-3916 | 38mm x 26mm x 16mm, 12 Deg | In distribution |
| 95-5284 | Trial, 38mm x 26mm x 14mm, 12 Deg | In distribution |
| 55-3322 | 32mm x 25mm x 22mm, 12 Deg | Withdrawn |
| 55-7020 | Ø6.0mm x 20mm | Withdrawn |
| 55-7045 | Ø6.0mm x 45mm | 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.