Vu a-POD Prime™
ALIF Implant Locking Screw 6.0mm X 20mm
3manufacturers in China registered for this device type
53catalogue 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) | K101310 |
| 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 |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Distribution end date | 2017-05-07 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 33-TA-3514 | 35x27mm, 14mm 8 degree | In distribution |
| 33-LT-3514 | 35x27mm, 14mm 12 degree | In distribution |
| 33-TA-3910 | 39x27mm, 10mm 8 degree | In distribution |
| 33-XT-3512 | 35x27mm, 12mm 15 degree | In distribution |
| 33-TA-3114 | 31x24mm, 14mm 8 degree | In distribution |
| 33-LT-3910 | 39x27mm, 10mm 12 degree | In distribution |
| 33-XT-3916 | 39x30mm, 16mm 15 Deg | In distribution |
| 33-TA-3510 | 35x27mm, 10mm 8 degree | In distribution |
| 33-15-6535 | 6.5x35mm | In distribution |
| 33-TA-3916 | 39x27mm, 16mm 8 degree | In distribution |
| 33-TA-3110 | 31x24mm, 10mm 8 degree | In distribution |
| 33-TA-3912 | 39x27mm, 12mm 8 degree | In distribution |
| 33-TA-3512 | 35x27mm, 12mm 8 degree | In distribution |
| 33-TA-3914 | 39x27mm, 14mm 8 degree | In distribution |
| 33-XT-3912 | 39x30mm, 12mm 15 Deg | In distribution |
| 33-LT-3914 | 39x27mm, 14mm 12 degree | In distribution |
| 33-LT-3516 | 35x27mm, 16mm 12 degree | In distribution |
| 33-15-6525 | 6.5x25mm | In distribution |
| 33-LT-3512 | 35x27mm, 12mm 12 degree | In distribution |
| 33-TA-3116 | 31x24mm, 16mm 8 degree | In distribution |
| 33-13-5530 | 5.5x30mm | In distribution |
| 33-XT-3116 | 31x24mm, 16mm 15 degree | In distribution |
| 33-XT-3516 | 35x27mm, 16mm 15 degree | In distribution |
| 33-XT-3914 | 39x30mm, 14mm 15 Deg | In distribution |
| 33-13-5525 | 5.5x25mm | In distribution |
| 33-LT-3110 | 31x24mm, 10mm 12 degree | In distribution |
| 33-LT-3912 | 39x27mm, 12mm 12 degree | In distribution |
| 33-LT-3510 | 35x27mm, 10mm 12 degree | In distribution |
| 33-13-5520 | 5.5x20mm | In distribution |
| 33-TA-3112 | 31x24mm, 12mm 8 degree | In distribution |
| 33-TA-3516 | 35x27mm, 16mm 8 degree | In distribution |
| 33-LT-3112 | 31x24mm, 12mm 12 degree | In distribution |
| 33-15-6530 | 6.5x30mm | In distribution |
| 33-XT-3112 | 31x24mm, 12mm 15 degree | In distribution |
| 33-15-6520 | 6.5x20mm | In distribution |
| 33-XT-3114 | 31x24mm, 14mm 15 degree | In distribution |
| 33-XT-3510 | 35x27mm, 10mm 15 degree | In distribution |
| 33-XT-3910 | 39x30mm, 10mm 15 Deg | In distribution |
| 33-XT-3514 | 35x27mm, 14mm 15 degree | In distribution |
| 33-XT-3110 | 31x24mm, 10mm 15 degree | In distribution |
| 33-13-5535 | 5.5x35mm | In distribution |
| 33-LT-3116 | 31x24mm, 16mm 12 degree | In distribution |
| 33-LT-3114 | 31x24mm, 14mm 12 degree | In distribution |
| 33-LT-3916 | 39x27mm, 16mm 12 degree | In distribution |
| 33-XT-3918 | 39x30mm, 18mm 15 degree | Withdrawn |
| 33-LT-3518 | 35x27mm 18mm 12Deg | Withdrawn |
| 33-XT-3518 | 35x27mm, 18mm 15 degree | Withdrawn |
| 33-XT-3118 | 31x24mm, 18mm 15 degree | Withdrawn |
| 33-TA-3918 | 39x30mm, 18mm 8 degree | Withdrawn |
| 33-LT-3118 | 31x24mm 18mm 12Deg | Withdrawn |
| 33-14-6020 | Withdrawn | |
| 33-TA-3518 | 35x27mm 18mm 8Deg | Withdrawn |
| 33-TA-3118 | 31x24mm 18mm 8Deg | 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.