Vu a-POD™
31x24mm Trial 10mm 12 deg. The Vu a-POD intervertebral body fusion device is comprised of polymer (PEEK OPTIMA® LT) concave cages. The PEEK cages include tantalumpins (or radiopaque…
31x24mm Trial 10mm 12 deg. The Vu a-POD intervertebral body fusion device is comprised of polymer (PEEK OPTIMA® LT) concave cages. The PEEK cages include tantalumpins (or radiopaque markers) for radiological evaluation. All pins are press fit into the PEEK material. The pins are placed in the implant on each end of the PEEK cages to allow easier radiological assessment of the position and orientation of the radiolucent PEEK cage.
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) | K080822 |
| Record published | 2015-09-24 |
| Record revised | 2025-10-24 (version 9) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 21-TA-3514 | 35x27mm, 14mm 8° | In distribution |
| 21-TA-3112 | 31x24mm, 12mm 8° | In distribution |
| 21-XT-3912 | 39x30mm, 12mm 15° | In distribution |
| 21-21-3110 | 31x24mm 10mm 12° | In distribution |
| 21-23-3908 | 39x30mm, 8mm 8 deg | In distribution |
| 21-23-3108 | 31x24mm, 8mm 8 deg | In distribution |
| 21-LT-2712 | 4.0 x 14mm | In distribution |
| 21-20-3914 | 39x30mm 14mm 8° | In distribution |
| 21-LT-3112 | 31x24mm, 12mm 12° | In distribution |
| 21-LT-2710 | 4.0 x 12mm | In distribution |
| 21-25-3114 | 31x24mm, 14mm 15 deg | In distribution |
| 21-21-3512 | 35x27mm 12mm 12° | In distribution |
| 21-TA-2710 | 27x21mm, 10mm 8° | In distribution |
| 21-40-0245 | 45 Degree | In distribution |
| 21-23-3116 | 31x24mm, 16mm 8 deg | In distribution |
| 21-24-2716 | 27x21mm, 16mm 12 deg | In distribution |
| 21-TA-3116 | 31x24mm, 16mm 8° | In distribution |
| 21-21-2712 | 27x21mm 12mm 12° | In distribution |
| 21-24-2708 | 27x21mm, 8mm 12 deg | In distribution |
| 21-XT-3116 | 31x24mm, 16mm 15° | In distribution |
| 21-23-3910 | 39x30mm, 10mm 8 deg | In distribution |
| 21-24-3516 | 35x27mm, 16mm 12 deg | In distribution |
| 21-XT-3914 | 39x30mm, 14mm 15° | In distribution |
| 21-21-2708 | 27x21mm 8mm 12° | In distribution |
| 21-LT-2708 | 4.0 x 10mm | In distribution |
| 21-XT-3112 | 31x24mm, 12mm 15° | In distribution |
| 21-23-2714 | 27x21mm, 14mm 8 deg | In distribution |
| 21-23-3110 | 31x24mm, 10mm 8 deg | In distribution |
| 21-XT-3512 | 35x27mm, 12mm 15° | In distribution |
| 21-LT-3116 | 31x24mm, 16mm 12° | In distribution |
| 21-22-3112 | 31x24mm 12mm 15° | In distribution |
| 21-21-3116 | 31x24mm 16mm 12° | In distribution |
| 21-25-3516 | 35x27mm, 16mm 15 deg | In distribution |
| 21-23-3512 | 35x27mm, 12mm 8 deg | In distribution |
| 21-TA-3910 | 39x30mm, 10mm 8° | In distribution |
| 21-24-3914 | 39x30mm, 14mm 12 deg | In distribution |
| 21-24-3108 | 31x24mm, 8mm 12 deg | In distribution |
| 21-21-3114 | 31x24mm 14mm 12° | In distribution |
| 21-24-3508 | 35x27mm, 8mm 12 deg | In distribution |
| 21-11-3516 | 35×27 16mm | In distribution |
| 21-XT-3114 | 31x24mm, 14mm 15° | In distribution |
| 21-20-2714 | 27x21mm 14mm 8° | In distribution |
| 21-XT-3514 | 35x27mm, 14mm 15° | In distribution |
| 21-20-3516 | 35x27mm 16mm 8° | In distribution |
| 21-21-3108 | 31x24mm 8mm 12° | In distribution |
| 21-TA-2712 | 27x21mm, 12mm 8° | In distribution |
| 21-LT-3912 | 39x30mm, 12mm 12° | In distribution |
| 21-11-3112 | 31×24 12mm | In distribution |
| 21-25-3512 | 35x27mm, 12mm 15 deg | In distribution |
| 21-21-3508 | 35x27mm 8mm 12° | In distribution |
| 21-TA-3114 | 31x24mm, 14mm 8° | In distribution |
| 21-11-3914 | 39×30 14mm | In distribution |
| 21-TA-3914 | 39x30mm, 14mm 8° | In distribution |
| 21-40-0200 | In distribution | |
| 21-23-3516 | 35x27mm, 16mm 8 deg | In distribution |
| 21-20-2716 | 27x21mm 16mm 8° | In distribution |
| 21-21-3112 | 31x24mm 12mm 12° | In distribution |
| 21-24-3112 | 31x24mm, 12mm 12 deg | In distribution |
| 21-TA-3516 | 35x27mm, 16mm 8° | In distribution |
| 21-LT-3908 | 39x30mm, 8mm 12° | In distribution |
| 21-23-3514 | 35x27mm, 14mm 8 deg | In distribution |
| 21-25-3514 | 35x27mm, 14mm 15 deg | In distribution |
| 21-21-3914 | 39x30mm 14mm 12° | In distribution |
| 21-21-2716 | 27x21mm 16mm 12° | In distribution |
| 21-24-3916 | 39x30mm, 16mm 12 deg | In distribution |
| 21-TA-3512 | 35x27mm, 12mm 8° | In distribution |
| 21-11-3116 | 31×24 16mm | In distribution |
| 21-11-3912 | 39×30 12mm | In distribution |
| 21-20-3116 | 31x24mm 16mm 8° | In distribution |
| 21-TA-3916 | 39x30mm, 16mm 8° | In distribution |
| 21-LT-3916 | 39x30mm, 16mm 12° | In distribution |
| 21-24-3510 | 35x27mm, 10mm 12 deg | In distribution |
| 21-21-2710 | 27x21mm 10mm 12° | In distribution |
| 21-20-2708 | 27x21mm 8mm 8° | In distribution |
| 21-23-3112 | 31x24mm, 12mm 8 deg | In distribution |
| 21-24-2712 | 27x21mm, 12mm 12 deg | In distribution |
| 21-24-3512 | 35x27mm, 12mm 12 deg | In distribution |
| 21-LT-3108 | 4.5 x 10mm | In distribution |
| 33-40-0245 | 45 Degree | In distribution |
| 21-24-3912 | 39x30mm, 12mm 12 deg | In distribution |
| 21-20-3510 | 35x27mm 10mm 8° | In distribution |
| 21-LT-3510 | 35x27mm, 10mm 12° | In distribution |
| 21-25-3916 | 39x30mm, 16mm 15 deg | In distribution |
| 21-20-3114 | 31x24mm 14mm 8° | In distribution |
| 21-20-3908 | 39x30mm 8mm 8° | In distribution |
| 21-24-3514 | 35x27mm, 14mm 12 deg | In distribution |
| 21-LT-2714 | 4.0 x 16mm | In distribution |
| 21-23-3916 | 39x30mm, 16mm 8 deg | In distribution |
| 21-40-0290 | 90 Degree | In distribution |
| 21-LT-3516 | 35x27mm, 16mm 12° | In distribution |
| 21-25-3912 | 39x30mm, 12mm 15 deg | In distribution |
| 21-TA-2716 | 27x21mm, 16mm 8° | In distribution |
| 21-20-3912 | 39x30mm 12mm 8° | In distribution |
| 21-23-3912 | 39x30mm, 12mm 8 deg | In distribution |
| 21-LT-3508 | 35x27mm, 8mm 12° | In distribution |
| 21-23-3508 | 35x27mm, 8mm 8 deg | In distribution |
| 21-24-2710 | 27x21mm, 10mm 12 deg | In distribution |
| 21-11-3512 | 35×27 12mm | In distribution |
| 21-21-3514 | 35x27mm 14mm 12° | In distribution |
| 21-TA-3108 | 31x24mm ,8mm 8° | In distribution |
| 21-22-3914 | 39x30mm 14mm 15° | In distribution |
| 21-XT-3916 | 39x30mm, 16mm 15° | In distribution |
| 21-20-3916 | 39x30mm 16mm 8° | In distribution |
| 21-23-3114 | 31x24mm, 14mm 8 deg | In distribution |
| 21-24-3110 | 31x24mm, 10mm 12 deg | In distribution |
| 21-LT-3512 | 35x27mm, 12mm 12° | In distribution |
| 21-24-3114 | 31x24mm, 14mm 12 deg | In distribution |
| 21-24-3910 | 39x30mm, 10mm 12 deg | In distribution |
| 21-TA-3110 | 31x24mm, 10mm 8° | In distribution |
| 21-20-3910 | 39x30mm 10mm 8° | In distribution |
| 21-22-3516 | 35x27mm 16mm 15° | In distribution |
| 21-25-3116 | 31x24mm, 16mm 15 deg | In distribution |
| 21-24-3116 | 31x24mm, 16mm 12 deg | In distribution |
| 21-21-3908 | 39x30mm 8mm 12° | In distribution |
| 21-24-3908 | 39x30mm, 8mm 12 deg | In distribution |
| 21-24-2714 | 27x21mm, 14mm 12 deg | In distribution |
| 21-20-2712 | 27x21mm 12mm 8° | In distribution |
| 21-23-2716 | 27x21mm, 16mm 8 deg | In distribution |
| 21-40-0110 | In distribution | |
| 21-21-2714 | 27x21mm 14mm 12° | In distribution |
| 21-11-2712 | 27×21 12mm | In distribution |
| 21-11-3508 | 35×27 8mm | In distribution |
| 21-21-3510 | 35x27mm 10mm 12° | In distribution |
| 21-20-2710 | 27x21mm 10mm 8° | In distribution |
| 21-23-3510 | 35x27mm, 10mm 8 deg | In distribution |
| 21-20-3110 | 31x24mm 10mm 8° | In distribution |
| 21-22-3116 | 31x24mm 16mm 15° | In distribution |
| 21-20-3112 | 31x24mm 12mm 8° | In distribution |
| 21-LT-3914 | 39x30mm, 14mm 12° | In distribution |
| 21-LT-3114 | 31x24mm, 14mm 12° | In distribution |
| 21-XT-3516 | 35x27mm, 16mm 15° | In distribution |
| 21-22-3912 | 39x30mm 12mm 15° | In distribution |
| 21-22-3514 | 35x27mm 14mm 15° | In distribution |
| 21-23-2710 | 27x21mm, 10mm 8 deg | In distribution |
| 21-40-0215 | 15 Degree | In distribution |
| 21-11-3908 | 39×30 8mm | In distribution |
| 21-20-3508 | 35x27mm 8mm 8° | In distribution |
| 21-23-2712 | 27x21mm, 12mm 8 deg | In distribution |
| 21-LT-3514 | 35x27mm, 14mm 12° | In distribution |
| 21-20-3108 | 31x24mm 8mm 8° | In distribution |
| 21-TA-2714 | 27x21mm, 14mm 8° | In distribution |
| 21-21-3516 | 35x27mm 16mm 12° | In distribution |
| 21-TA-2708 | 27x21mm ,8mm 8° | In distribution |
| 21-LT-3110 | 4.5 x 12mm | In distribution |
| 21-20-3512 | 35x27mm 12mm 8° | In distribution |
| 21-22-3114 | 31x24mm 14mm 15° | In distribution |
| 21-23-2708 | 27x21mm, 8mm 8 deg | In distribution |
| 21-22-3916 | 39x30mm 16mm 15° | In distribution |
| 21-11-3510 | 35×27 10mm | In distribution |
| 21-TA-3510 | 35x27mm, 10mm 8° | In distribution |
| 21-11-3108 | 31×24 8mm | In distribution |
| 21-25-3112 | 31x24mm, 12mm 15 deg | In distribution |
| 21-11-2708 | 27×21 8mm | In distribution |
| 21-22-3512 | 35x27mm 12mm 15° | In distribution |
| 21-11-3514 | 35×27 14mm | In distribution |
| 21-11-3916 | 39×30 16mm | In distribution |
| 21-21-3910 | 39x30mm 10mm 12° | In distribution |
| 21-20-3514 | 35x27mm 14mm 8° | In distribution |
| 21-21-3912 | 39x30mm 12mm 12° | In distribution |
| 21-25-3914 | 39x30mm, 14mm 15 deg | In distribution |
| 21-LT-3910 | 39x30mm, 10mm 12° | In distribution |
| 21-11-2710 | 27×21 10mm | In distribution |
| 21-LT-2716 | 4.0 x 18mm | In distribution |
| 21-23-3914 | 39x30mm, 14mm 8 deg | In distribution |
| 21-11-3910 | 39×30 10mm | In distribution |
| 21-11-3110 | 31×24 10mm | In distribution |
| 21-TA-3908 | 39x30mm ,8mm 8° | In distribution |
| 21-TA-3508 | 35x27mm, 8mm 8° | In distribution |
| 21-11-3114 | 31×24 14mm | In distribution |
| 21-21-3916 | 39x30mm 16mm 12° | In distribution |
| 21-TA-3912 | 39x30mm, 12mm 8° | 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.