Vu a-POD Prime NanoMetalene
Vu a-POD Prime NanoMetalene is an anterior lumbar interbody spacer with a PEEK body and a one-micrometre titanium surface layer. Its central window holds bone graft, while spikes or knurls…
Vu a-POD Prime NanoMetalene is an anterior lumbar interbody spacer with a PEEK body and a one-micrometre titanium surface layer. Its central window holds bone graft, while spikes or knurls engage adjacent vertebral endplates.
Tantalum markers show the radiolucent spacer on imaging. The spacer can be combined with two bone screws, a SpinPlate or both, according to the fixation configuration.
Listed Item
Prime NM Implant, 39x30mm x 16mm, 15 Deg
Configuration-Dependent Fixation
Bone screws, with or without the SpinPlate, provide the standalone configuration. SpinPlate alone requires supplemental fixation, and implants with lordosis greater than 20 degrees also require additional fixation. The spacer is supplied sterile; screws and SpinPlate are supplied nonsterile for preparation at the healthcare facility.
3manufacturers in China registered for this device type
172catalogue 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) | K162351 |
| Record published | 2016-12-06 |
| Record revised | 2025-10-24 (version 6) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 35-90-1615 | 39x30mm x 16mm, 15 Deg | In distribution |
| 33-36-3910 | 39X27MM , 10mm 10DEG | In distribution |
| 35-30-1615 | 43x30mm x 16mm 15 Deg | In distribution |
| 33-28-3114 | 31x24mm x 14mm 20 Deg | In distribution |
| 35-90-1215 | 39x30mm x 12mm, 15 Deg | In distribution |
| 33-14-6020 | 6.0 Dia. X 20mm | In distribution |
| 33-27-3512 | 35x27mm x 12mm 15 Deg | In distribution |
| 35-14-1820 | 31x24mm x 18mm, 20 Deg | In distribution |
| 33-48-3918 | 39X27MM , 18mm 25DEG | In distribution |
| 35-90-1010 | 39x30mm x 10mm, 10 Deg | In distribution |
| 33-47-3518 | 35X27MM, 18mm 25DEG | In distribution |
| 35-97-1425 | N/A | In distribution |
| 35-14-1620 | 31x24mm x 16mm, 20 Deg | In distribution |
| 33-26-3110 | 31x24mm x 10mm 10 Deg | In distribution |
| 33-26-3916 | 39x30mm x 16mm 10 Deg | In distribution |
| 33-37-4312 | 43X30MM , 12mm 15DEG | In distribution |
| 33-48-3916 | 39X27MM , 16mm 25DEG | In distribution |
| 35-90-1625 | N/A | In distribution |
| 33-38-4314 | 43X30MM , 14mm 20DEG | In distribution |
| 33-29-3918 | 39x30mm x 18mm 30 Deg | In distribution |
| 33-28-3516 | 35x27mm x 16mm 20 Deg | In distribution |
| 35-13-5500 | In distribution | |
| 33-28-3518 | 35x27mm x 18mm 20 Deg | In distribution |
| 35-57-1210 | 35x27mm x 12mm, 10 Deg | In distribution |
| 33-37-3914 | 39X27MM , 14mm 15DEG | In distribution |
| 35-30-1620 | 43x30mm x 16mm 20 Deg | In distribution |
| 35-57-1410 | 35x27mm x 14mm, 10 Deg | In distribution |
| 35-57-1620 | 35x27mm x 16mm, 20 Deg | In distribution |
| 35-90-1610 | 39x30mm x 16mm, 10 Deg | In distribution |
| 35-97-1415 | 39x27mm x 14mm, 15 Deg | In distribution |
| 33-14-5535 | 5.5 Dia. X 35mm | In distribution |
| 35-30-1420 | 43x30mm x 14mm 20 Deg | In distribution |
| 33-26-3512 | 35x27mm x 12mm 10 Deg | In distribution |
| 33-38-3918 | 39X27MM , 18mm 20DEG | In distribution |
| 33-18-6530 | In distribution | |
| 35-14-1610 | 31x24mm x 16mm, 10 Deg | In distribution |
| 35-57-1010 | 35x27mm x 10mm, 10 Deg | In distribution |
| 35-30-1820 | 43x30mm x 18mm 20 Deg | In distribution |
| 33-26-3116 | 31x24mm x 16mm 10 Deg | In distribution |
| 35-90-1420 | 39x30mm x 14mm, 20 Deg | In distribution |
| 33-26-3510 | 35x27mm x 10mm 10 Deg | In distribution |
| 21-40-1110 | In distribution | |
| 33-29-3118 | 31x24mm x 18mm 30 Deg | In distribution |
| 33-36-4310 | 43X30MM , 10mm 10DEG | In distribution |
| 35-97-1625 | N/A | In distribution |
| 33-14-5530 | 5.5 Dia. X 30mm | In distribution |
| 33-46-3114 | 31X24MM, 14mm 25DEG | In distribution |
| 33-49-3914 | 39X30MM , 14mm 25DEG | In distribution |
| 33-26-3914 | 39x30mm x 14mm 10 Deg | In distribution |
| 33-26-3514 | 35x27mm x 14mm 10 Deg | In distribution |
| 33-18-5530 | In distribution | |
| 35-97-1010 | 39x27mm x 10mm, 10 Deg | In distribution |
| 33-14-6530 | 6.5 Dia. X 30mm | In distribution |
| 35-97-1620 | 39x27mm x 16mm, 20 Deg | In distribution |
| 33-27-3114 | 31x24mm x 14mm 15 Deg | In distribution |
| 33-39-4320 | 43X30MM , 20mm 30DEG | In distribution |
| 33-36-3912 | 39X27MM , 12mm 10DEG | In distribution |
| 33-27-3912 | 39x30mm x 12mm 15 Deg | In distribution |
| 33-29-3920 | 39x30mm x 20mm 30 Deg | In distribution |
| 35-57-2030 | 35x27mm x 20mm, 30 Deg | In distribution |
| 35-90-1415 | 39x30mm x 14mm, 15 Deg | In distribution |
| 35-90-1410 | 39x30mm x 14mm, 10 Deg | In distribution |
| 33-14-5525 | 5.5 Dia. X 25mm | In distribution |
| 35-90-1210 | 39x30mm x 12mm, 10 Deg | In distribution |
| 33-38-4316 | 43X30MM , 16mm 20DEG | In distribution |
| 35-30-1410 | 43x30mm x 14mm 10 Deg | In distribution |
| 33-28-3514 | 35x27mm x 14mm 20 Deg | In distribution |
| 35-57-1830 | 35x27mm x 18mm, 30 Deg | In distribution |
| 35-30-1830 | 43x30mm x 18mm 30 Deg | In distribution |
| 35-97-1420 | 39x27mm x 14mm, 20 Deg | In distribution |
| 33-26-3114 | 31x24mm x 14mm 10 Deg | In distribution |
| 35-14-1415 | 31x24mm x 14mm, 15 Deg | In distribution |
| 33-18-5520 | In distribution | |
| 33-50-4316 | 43X30MM , 16mm 25DEG | In distribution |
| 33-18-6025 | In distribution | |
| 35-97-1830 | 39x27mm x 18mm, 30 Deg | In distribution |
| 33-37-4316 | 43X30MM , 16mm 15DEG | In distribution |
| 33-37-4314 | 43X30MM , 14mm 15DEG | In distribution |
| 33-27-3116 | 31x24mm x 16mm 15 Deg | In distribution |
| 35-57-1610 | 35x27mm x 16mm, 10 Deg | In distribution |
| 35-14-1825 | N/A | In distribution |
| 33-14-6535 | 6.5 Dia. X 35mm | In distribution |
| 33-26-3912 | 39x30mm x 12mm 10 Deg | In distribution |
| 35-97-1410 | 39x27mm x 14mm, 10 Deg | In distribution |
| 35-30-1610 | 43x30mm x 16mm 10 Deg | In distribution |
| 33-48-3914 | 39X27MM , 14mm 25DEG | In distribution |
| 35-14-1420 | 31x24mm x 14mm, 20 Deg | In distribution |
| 33-29-3520 | 35x27mm x 20mm 30 Deg | In distribution |
| 33-27-3112 | 31x24mm x 12mm 15 Deg | In distribution |
| 35-14-1215 | 31x24mm x 12mm, 15 Deg | In distribution |
| 33-28-3116 | 31x24mm x 16mm 20 Deg | In distribution |
| 35-97-1825 | N/A | In distribution |
| 35-14-2030 | 31x24mm x 20mm, 30 Deg | In distribution |
| 35-30-1215 | 43x30mm x 12mm 15 Deg | In distribution |
| 33-36-4316 | 43X30MM , 16mm 10DEG | In distribution |
| 35-90-1825 | N/A | In distribution |
| 35-90-1820 | 39x30mm x 18mm, 20 Deg | In distribution |
| 35-90-1620 | 39x30mm x 16mm, 20 Deg | In distribution |
| 33-26-3516 | 35x27mm x 16mm 10 Deg | In distribution |
| 33-47-3514 | 35X27MM, 14mm 25DEG | In distribution |
| 33-14-6030 | 6.0 Dia. X 30mm | In distribution |
| 33-36-4312 | 43X30MM , 12mm 10DEG | In distribution |
| 33-39-4318 | 43X30MM , 18mm 30DEG | In distribution |
| 33-46-3116 | 31X24MM, 16mm 25DEG | In distribution |
| 35-97-1210 | 39x27mm x 12mm, 10 Deg | In distribution |
| 33-18-5525 | In distribution | |
| 33-37-3912 | 39X27MM , 12mm 15DEG | In distribution |
| 35-57-1625 | N/A | In distribution |
| 35-14-1425 | N/A | In distribution |
| 33-47-3516 | 35X27MM, 16mm 25DEG | In distribution |
| 33-27-3516 | 35x27mm x 16mm 15 Deg | In distribution |
| 35-97-1615 | 39x27mm x 16mm, 15 Deg | In distribution |
| 33-46-3118 | 31X24MM, 18mm 25DEG | In distribution |
| 33-27-3916 | 39x30mm x 16mm 15 Deg | In distribution |
| 33-29-3518 | 35x27mm x 18mm 30 Deg | In distribution |
| 35-14-1010 | 31x24mm x 10mm, 10 Deg | In distribution |
| 33-18-6020 | In distribution | |
| 33-14-5527 | 5.5 Dia. X 27mm | In distribution |
| 35-30-1625 | N/A | In distribution |
| 33-14-5520 | 5.5 Dia. X 20mm | In distribution |
| 33-28-3916 | 39x30mm x 16mm 20 Deg | In distribution |
| 33-28-3914 | 39x30mm x 14mm 20 Deg | In distribution |
| 33-37-3916 | 39X27MM , 16mm 15DEG | In distribution |
| 33-49-3916 | 39X30MM , 16mm 25DEG | In distribution |
| 35-97-1820 | 39x27mm x 18mm, 20 Deg | In distribution |
| 33-14-6525 | 6.5 Dia. X 25mm | In distribution |
| 33-36-4314 | 43X30MM , 14mm 10DEG | In distribution |
| 35-57-1420 | 35x27mm x 14mm, 20 Deg | In distribution |
| 33-38-3914 | 39X27MM , 14mm 20DEG | In distribution |
| 33-29-3120 | 31x24mm x 20mm 30 Deg | In distribution |
| 35-30-1210 | 43x30mm x 12mm 10 Deg | In distribution |
| 35-30-2030 | 43x30mm x 20mm 30 Deg | In distribution |
| 33-28-3118 | 31x24mm x 18mm 20 Deg | In distribution |
| 33-14-6035 | 6.0 Dia. X 35mm | In distribution |
| 33-39-3918 | 39X27MM , 18mm 30DEG | In distribution |
| 35-90-2030 | 39x30mm x 20mm, 30 Deg | In distribution |
| 33-14-6027 | 6.0 Dia. X 27mm | In distribution |
| 35-90-1830 | 39x30mm x 18mm, 30 Deg | In distribution |
| 35-57-1215 | 35x27mm x 12mm, 15 Deg | In distribution |
| 35-97-2030 | 39x27mm x 20mm, 30 Deg | In distribution |
| 33-14-6520 | 6.5 Dia. X 20mm | In distribution |
| 33-36-3914 | 39X27MM , 14mm 10DEG | In distribution |
| 33-50-4314 | 43X30MM , 14mm 25DEG | In distribution |
| 33-14-6025 | 6.0 Dia. X 25mm | In distribution |
| 33-27-3914 | 39x30mm x 14mm 15 Deg | In distribution |
| 33-28-3918 | 39x30mm x 18mm 20 Deg | In distribution |
| 35-14-1615 | 31x24mm x 16mm, 15 Deg | In distribution |
| 33-27-3514 | 35x27mm x 14mm 15 Deg | In distribution |
| 33-14-6527 | 6.5 Dia. X 27mm | In distribution |
| 33-18-6520 | In distribution | |
| 33-38-4318 | 43X30MM , 18mm 20DEG | In distribution |
| 35-30-1010 | 43x30mm x 10mm 10 Deg | In distribution |
| 35-97-1610 | 39x27mm x 16mm, 10 Deg | In distribution |
| 33-26-3910 | 39x30mm x 10mm 10 Deg | In distribution |
| 35-30-1825 | N/A | In distribution |
| 35-14-1410 | 31x24mm x 14mm, 10 Deg | In distribution |
| 33-36-3916 | 39X27MM , 16mm 10DEG | In distribution |
| 35-57-1820 | 35x27mm x 18mm, 20 Deg | In distribution |
| 35-30-1415 | 43x30mm x 14mm 15 Deg | In distribution |
| 33-26-3112 | 31x24mm x 12mm 10 Deg | In distribution |
| 33-38-3916 | 39X27MM , 16mm 20DEG | In distribution |
| 35-57-1425 | N/A | In distribution |
| 35-57-1615 | 35x27mm x 16mm, 15 Deg | In distribution |
| 35-14-1625 | N/A | In distribution |
| 35-57-1825 | N/A | In distribution |
| 35-57-1415 | 35x27mm x 14mm, 15 Deg | In distribution |
| 35-14-1830 | 31x24mm x 18mm, 30 Deg | In distribution |
| 35-97-1215 | 39x27mm x 12mm, 15 Deg | In distribution |
| 33-18-6030 | In distribution | |
| 33-39-3920 | 39X27MM , 20mm 30DEG | In distribution |
| 35-14-1210 | 31x24mm x 12mm, 10 Deg | In distribution |
| 33-18-6525 | 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 |
|---|---|
| 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.