Nexxt Matrixx® Stand Alone Alif System
Nexxt Matrixx Stand Alone ALIF System combines a titanium alloy interbody implant with separate fixation screws. The implant’s roughened outer frame provides structural support, while an…
Nexxt Matrixx Stand Alone ALIF System combines a titanium alloy interbody implant with separate fixation screws. The implant’s roughened outer frame provides structural support, while an internal cavity accommodates bone graft.
The additively manufactured body includes a lattice with pores from 300 to 700 micrometers. Traditionally machined screws are secured to the interbody by preassembled turn-lock mechanisms.
Listed Item
Coronal SA ALIF, 22Dx36Wx10H 18°x04°
Angle-Dependent Fixation
Cages at 20 degrees of lordosis or less use the supplied bone screws without additional fixation. Cages above 20 degrees require supplemental fixation. Different dimensional combinations provide anatomical fit within these fixation configurations.
3manufacturers in China registered for this device type
158catalogue numbers in this listing
1510(k) clearance
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 | Nexxt Spine LLC, 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 | Contract manufacturer, Complaint-file establishment, Manufacturer |
| 510(k) | K202230 |
| Record published | 2021-02-24 |
| Record revised | 2023-04-04 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, serial number |
| Sizes | Width 32 to 40 mm; depth 22 to 30 mm; angle 8 to 25 °; height 6 to 20 mm; outer diameter 5 to 5.5 mm; length 20 to 35 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 61-2736-20-20-SP | Width 36 mm | In distribution |
| I61-TR3040-10-14 | In distribution | |
| C61-01-02 | In distribution | |
| I61-TR2432-16-25 | In distribution | |
| I61-TR2736-18-20 | In distribution | |
| 61-3040-10-14-SP | Width 40 mm | In distribution |
| I61-TR2736-10-14 | In distribution | |
| 61-2736-20-14-SP | Width 36 mm | In distribution |
| 61-3040-16-25-SP | Width 40 mm | In distribution |
| I61-TR2432-10-14 | In distribution | |
| I61-TR2736-16-20 | In distribution | |
| I61-TR2736-14-25 | In distribution | |
| 61-3040-14-20-SP | Width 40 mm | In distribution |
| 61-2432-12-20-SP | Width 32 mm | In distribution |
| 61-3040-10-8-SP | Width 40 mm | In distribution |
| C61-02-04 | In distribution | |
| 61-2432-12-8-SP | Width 32 mm | In distribution |
| I61-TR3040-18-14 | In distribution | |
| 61-50-30-SP | Outer Diameter 5 mm | In distribution |
| I61-TR2432-16-20 | In distribution | |
| 61-2432-10-8-SP | Width 32 mm | In distribution |
| 61-55-25-SP | Outer Diameter 5.5 mm | In distribution |
| I61-TR2432-18-20 | In distribution | |
| 61-3040-20-14-SP | Width 40 mm | In distribution |
| 61-2432-20-8-SP | Width 32 mm | In distribution |
| C61-02-02 | In distribution | |
| I61-TR3040-20-14 | In distribution | |
| I61-TR2432-12-08 | In distribution | |
| I61-TR2736-14-08 | In distribution | |
| I61-TR2432-12-20 | In distribution | |
| I61-TR3040-14-25 | In distribution | |
| 61-55-20-SP | Outer Diameter 5.5 mm | In distribution |
| 61-3040-14-25-SP | Width 40 mm | In distribution |
| I61-TR2432-18-14 | In distribution | |
| 61-2736-20-25-SP | Width 36 mm | In distribution |
| 61C-2236-10-18-04-SP | Angle 18 ° | In distribution |
| 61-3040-12-14-SP | Width 40 mm | In distribution |
| 61-2736-18-14-SP | Width 36 mm | In distribution |
| I61-01-02 | In distribution | |
| I61-TR2736-10-08 | In distribution | |
| I61-TR2432-20-25 | In distribution | |
| 61A-5525-SP | Outer Diameter 5.5 mm | In distribution |
| 61A-5035-SP | Outer Diameter 5.0 mm | In distribution |
| I61-TR3040-08-08 | In distribution | |
| 61-50-25-SP | Outer Diameter 5 mm | In distribution |
| 61-3040-18-20-SP | Width 40 mm | In distribution |
| 61-3040-16-8-SP | Width 40 mm | In distribution |
| 61-2736-20-8-SP | Width 36 mm | In distribution |
| 61-2432-18-20-SP | Width 32 mm | In distribution |
| I61-TR3040-20-25 | In distribution | |
| 61-2736-18-20-SP | Width 36 mm | In distribution |
| 61-2736-12-20-SP | Width 36 mm | In distribution |
| 61-2432-18-8-SP | Width 32 mm | In distribution |
| 61A-5535-SP | Outer Diameter 5.5 mm | In distribution |
| I61-TR2736-20-14 | In distribution | |
| 61-3040-16-14-SP | Width 40 mm | In distribution |
| C61-02-03 | In distribution | |
| I61-TR2736-12-08 | In distribution | |
| I61-TR2736-14-20 | In distribution | |
| 61-2432-16-14-SP | Width 32 mm | In distribution |
| I61-TR3040-16-20 | In distribution | |
| I61-TR2432-14-25 | In distribution | |
| 61-2736-10-8-SP | Width 36 mm | In distribution |
| I61-TR3040-16-08 | In distribution | |
| C61-02-01 | In distribution | |
| 61-2432-14-8-SP | Width 32 mm | In distribution |
| 61-3040-16-20-SP | Width 40 mm | In distribution |
| I61-TR3040-16-25 | In distribution | |
| 61-3040-12-8-SP | Width 40 mm | In distribution |
| 61-2736-14-25-SP | Width 36 mm | In distribution |
| I61-TR3040-14-14 | In distribution | |
| 61-2736-12-8-SP | Width 36 mm | In distribution |
| 61-2432-12-14-SP | Width 32 mm | In distribution |
| 61-3040-20-25-SP | Width 40 mm | In distribution |
| I61-01-03 | In distribution | |
| 61-2432-10-14-SP | Width 32 mm | In distribution |
| I61-TR2432-12-14 | In distribution | |
| I61-TR2736-16-14 | In distribution | |
| I61-TR3040-18-20 | In distribution | |
| 61-3040-18-25-SP | Width 40 mm | In distribution |
| I61-TR2736-20-25 | In distribution | |
| I61-TR2736-18-14 | In distribution | |
| 61-2432-14-20-SP | Width 32 mm | In distribution |
| 61-2432-20-14-SP | Width 32 mm | In distribution |
| I61-TR2736-20-20 | In distribution | |
| I61-TR3040-12-14 | In distribution | |
| 61-55-15-SP | Outer Diameter 5.5 mm | In distribution |
| I61-TR2432-08-14 | In distribution | |
| I61-TR3040-14-20 | In distribution | |
| I61-TR3040-16-14 | In distribution | |
| 61-2432-16-25-SP | Width 32 mm | In distribution |
| I61-TR2432-10-08 | In distribution | |
| I61-02-01 | In distribution | |
| 61-2736-14-14-SP | Width 36 mm | In distribution |
| I61-TR3040-14-08 | In distribution | |
| 61-2736-18-25-SP | Width 36 mm | In distribution |
| I61-TR2432-16-14 | In distribution | |
| 61-2736-12-14-SP | Width 36 mm | In distribution |
| I61-TR3040-10-08 | In distribution | |
| 61-3040-18-8-SP | Width 40 mm | In distribution |
| I61-TR3040-08-14 | In distribution | |
| 61A-5030-SP | Outer Diameter 5.0 mm | In distribution |
| I61-TR2736-18-25 | In distribution | |
| I61-TR2736-12-14 | In distribution | |
| 61-3040-14-14-SP | Width 40 mm | In distribution |
| I61-TR3040-20-20 | In distribution | |
| 61A-5530-SP | Outer Diameter 5.5 mm | In distribution |
| I61-TR2432-14-20 | In distribution | |
| 61A-5020-SP | Outer Diameter 5.0 mm | In distribution |
| I61-TR3040-12-08 | In distribution | |
| 61-2432-18-14-SP | Width 32 mm | In distribution |
| 61-2736-14-20-SP | Width 36 mm | In distribution |
| I61-TR2432-14-08 | In distribution | |
| 61-3040-20-8-SP | Width 40 mm | In distribution |
| I61-TR2736-08-08 | In distribution | |
| 61-2736-16-8-SP | Width 36 mm | In distribution |
| I61-TR2736-16-08 | In distribution | |
| I61-TR2736-12-20 | In distribution | |
| C61-02-05 | In distribution | |
| 61-2432-20-20-SP | Width 32 mm | In distribution |
| 61-3040-14-8-SP | Width 40 mm | In distribution |
| 61-2432-20-25-SP | Width 32 mm | In distribution |
| I61-TR2432-16-08 | In distribution | |
| C60-02-02 | In distribution | |
| C61-01-01 | In distribution | |
| I61-TR3040-18-08 | In distribution | |
| I61-TR2432-20-14 | In distribution | |
| 61-2736-16-20-SP | Width 36 mm | In distribution |
| 61A-5025-SP | Outer Diameter 5.0 mm | In distribution |
| 61-2432-16-8-SP | Width 32 mm | In distribution |
| 61-2736-16-25-SP | Width 36 mm | In distribution |
| I61-TR2432-14-14 | In distribution | |
| 61A-5520-SP | Outer Diameter 5.5 mm | In distribution |
| I61-TR2736-14-14 | In distribution | |
| 61-3040-20-20-SP | Width 40 mm | In distribution |
| I61-TR2432-20-20 | In distribution | |
| 61C-2236-06-18-04-SP | Angle 18 ° | In distribution |
| 61-55-30-SP | Outer Diameter 5.5 mm | In distribution |
| 61-2736-14-8-SP | Width 36 mm | In distribution |
| 61-2432-16-20-SP | Width 32 mm | In distribution |
| I61-TR3040-18-25 | In distribution | |
| 61-2736-18-8-SP | Width 36 mm | In distribution |
| 61-2432-14-25-SP | Width 32 mm | In distribution |
| 61-2432-14-14-SP | Width 32 mm | In distribution |
| I61-TR2432-18-25 | In distribution | |
| 61-2736-10-14-SP | Width 36 mm | In distribution |
| I61-01-01 | In distribution | |
| 61-2432-18-25-SP | Width 32 mm | In distribution |
| 61-3040-18-14-SP | Width 40 mm | In distribution |
| 61-2736-16-14-SP | Width 36 mm | In distribution |
| 61-50-15-SP | Outer Diameter 5 mm | In distribution |
| I61-TR2432-08-08 | In distribution | |
| 61C-2236-08-18-04-SP | Angle 18 ° | In distribution |
| I61-TR2736-18-08 | In distribution | |
| 61-50-20-SP | Outer Diameter 5 mm | In distribution |
| I61-TR2736-16-25 | In distribution | |
| I61-TR2432-18-08 | In distribution | |
| I61-TR2736-08-14 | In distribution |
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 |
|---|---|
| K202230 | 2020-12-15 |
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.