Vu Apod™ – L
LATERAL IMPLANT, STANDARD SPINPLATE™, LORDOTIC, 10mm X 55mm X 10°
3manufacturers in China registered for this device type
110catalogue 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) | K112986 |
| 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 |
| Distribution end date | 2016-09-02 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 31-30-1250 | 12mm X 18mm X 50mm | In distribution |
| 31-29-1660 | 16mm X 18mm X 60mm | In distribution |
| 31-31-1655-12 | 16mm X 18mm X 55mm X 12° | In distribution |
| 31-29-0845 | 8mm X 18mm X 45mm | In distribution |
| 31-31-1240-12 | 12mm X 18mm X 40mm X 12° | In distribution |
| 31-32-1450-12 | 14mm X 18mm X 50mm X 12° | In distribution |
| 31-20-0845 | 8mm x 23mm x 45mm | In distribution |
| 31-29-0840 | 8mm X 18mm X 40mm | In distribution |
| 31-22-1245 | 12mm x 23mm x 45mm | In distribution |
| 31-25-1460-12 | 14mm X 23mm X 60mm X 12° | In distribution |
| 31-31-1045-10 | 10mm X 18mm X 45mm X 10° | In distribution |
| 31-29-0855 | 8mm X 18mm X 55mm | In distribution |
| 31-14-1250-12 | 12mmx 50mm x 12° | In distribution |
| 31-21-1650 | 16mm x 23mm x 50mm | In distribution |
| 31-25-1050-10 | 10mm X 23mm X 50mm X 10° | In distribution |
| 31-32-1045-10 | 10mm X 18mm X 45mm X 10° | In distribution |
| 31-14-1255-12 | 12mmx 55mm x 12° | In distribution |
| 31-13-1260 | 12mm x 60mm | In distribution |
| 31-20-0855 | 8mm x 23mm x 55mm | In distribution |
| 31-32-1240-12 | 12mm X 18mm X 40mm X 12° | In distribution |
| 31-29-1240 | 12mm X 18mm X 40mm | In distribution |
| 31-11-1055-10 | 10mm x 55mm x 10° | In distribution |
| 31-22-0850 | 8mm x 23mm x 50mm | In distribution |
| 31-20-0860 | 8mm x 23mm x 60mm | In distribution |
| 31-10-0850 | 8mm x 50mm | In distribution |
| 31-30-1655 | 16mm X 18mm X 55mm | In distribution |
| 31-23-1240-12 | 12mm x 23mm x 40mm x 12° | In distribution |
| 31-32-1655-12 | 16mm X 18mm X 55mm X 12° | In distribution |
| 31-39-0855-10 | 8mm X 18mm X 55mm X 10° | In distribution |
| 31-25-1250-12 | 12mm X 23mm X 50mm X 12° | In distribution |
| 31-30-1050 | 10mm X 18mm X 50mm | In distribution |
| 31-23-1255-12 | 12mm x 23mm x 55mm x 12° | In distribution |
| 31-10-1055 | 10mm x 55mm | In distribution |
| 31-13-1240 | 12mm x 40mm | In distribution |
| 31-30-1055 | 10mm X 18mm X 55mm | In distribution |
| 31-10-0840 | 8mm X 40mm | In distribution |
| 31-40-0294 | In distribution | |
| 31-21-1460 | 14mm x 23mm x 60mm | In distribution |
| 31-29-1445 | 14mm X 18mm X 45mm | In distribution |
| 31-29-1645 | 16mm X 18mm X 45mm | In distribution |
| 31-39-0840-10 | 8mm X 18mm X 40mm X 10° | In distribution |
| 31-37-0860-10 | 8mm X 23mm X 60mm X 10° | In distribution |
| 31-23-1045-10 | 10mm x 23mm x 45mm x 10° | In distribution |
| 31-31-1060-10 | 10mm X 18mm X 60mm X 10° | In distribution |
| 31-29-1260 | 12mm X 18mm X 60mm | In distribution |
| 31-31-1445-12 | 14mm X 18mm X 45mm X 12° | In distribution |
| 31-25-1660-12 | 16mm X 23mm X 60mm X 12° | In distribution |
| 31-22-1055 | 10mm x 23mm x 55mm | In distribution |
| 31-31-1660-12 | 16mm X 18mm X 60mm X 12° | In distribution |
| 31-10-0860 | 8mm x 60mm | In distribution |
| 31-22-1445 | 14mm x 23mm x 45mm | In distribution |
| 31-22-1040 | 10mm x 23mm x 40mm | In distribution |
| 31-24-1455-12 | 14mm X 23mm X 55mm X 12° | In distribution |
| 31-21-1445 | 14mm x 23mm x 45mm | In distribution |
| 31-31-1055-10 | 10mm X 18mm X 55mm X 10° | In distribution |
| 31-29-0860 | 8mm X 18mm X 60mm | In distribution |
| 31-21-1655 | 16mm x 23mm x 55mm | In distribution |
| 31-21-1645 | 16mm x 23mm x 45mm | In distribution |
| 31-40-0282 | In distribution | |
| 31-20-1060 | 10mm x 23mm x 60mm | In distribution |
| 31-30-1060 | 10mm X 18mm X 60mm | In distribution |
| 31-31-1645-12 | 16mm X 18mm X 45mm X 12° | In distribution |
| 31-32-1455-12 | 14mm X 18mm X 55mm X 12° | In distribution |
| 31-20-1050 | 10mm x 23mm x 50mm | In distribution |
| 31-29-1040 | 10mm X 18mm X 40mm | In distribution |
| 31-40-0280 | In distribution | |
| 31-25-1450-12 | 14mm X 23mm X 50mm X 12° | In distribution |
| 31-30-1450 | 14mm X 18mm X 50mm | In distribution |
| 31-32-1440-12 | 14mm X 18mm X 40mm X 12° | In distribution |
| 31-31-1455-12 | 14mm X 18mm X 55mm X 12° | In distribution |
| 31-22-0840 | 8mm x 23mm x 40mm | In distribution |
| 31-29-0850 | 8mm X 18mm X 50mm | In distribution |
| 31-23-1260-12 | 12mm X 23mm X 60mm X 12° | In distribution |
| 31-13-1245 | 12mm x 45mm | In distribution |
| 31-40-0281 | In distribution | |
| 31-25-1645-12 | 16mm X 23mm X 45mm X 12° | In distribution |
| 31-20-0850 | 8mm x 23mm x 50mm | In distribution |
| 31-32-1260-12 | 12mm X 18mm X 60mm X 12° | In distribution |
| 31-11-1040-10 | 10mm x 40mm x 10° | In distribution |
| 31-10-1050 | 10mm x 50mm | In distribution |
| 31-25-1055-10 | 10mm X 23mm X 55mm X 10° | In distribution |
| 31-31-1460-12 | 14mm X 18mm X 60mm X 12° | In distribution |
| 31-22-1650 | 16mm x 23mm x 50mm | In distribution |
| 31-25-1445-12 | 14mm X 23mm X 45mm X 12° | In distribution |
| 31-10-1060 | 10mm x 60mm | In distribution |
| 31-37-0850-10 | 8mm X 23mm X 50mm X 10° | In distribution |
| 31-32-1460-12 | 14mm X 18mm X 60mm X 12° | In distribution |
| 31-10-0845 | 8mm X 45mm | In distribution |
| 31-25-1455-12 | 14mm X 23mm X 55mm X 12° | In distribution |
| 31-24-1445-12 | 14mm X 23mm X 45mm X 12° | In distribution |
| 31-25-1060-10 | 10mm X 23mm X 60mm X 10° | In distribution |
| 31-25-1650-12 | 16mm X 23mm X 50mm X 12° | In distribution |
| 31-31-1650-12 | 16mm X 18mm X 50mm X 12° | In distribution |
| 31-32-1250-12 | 12mm X 18mm X 50mm X 12° | In distribution |
| 31-32-1055-10 | 10mm X 18mm X 55mm X 10° | In distribution |
| 31-30-1460 | 14mm X 18mm X 60mm | In distribution |
| 31-22-1250 | 12mm x 23mm x 50mm | In distribution |
| 31-29-1050 | 10mm X 18mm X 50mm | In distribution |
| 31-30-1260 | 12mm X 18mm X 60mm | In distribution |
| 31-32-1645-12 | 16mm X 18mm X 45mm X 12° | In distribution |
| 31-23-1245-12 | 12mm x 23mm x 45mm x 12° | In distribution |
| 31-22-1660 | 16mm x 23mm x 60mm | In distribution |
| 31-11-1050-10 | 10mm x 50mm x 10° | In distribution |
| 31-24-1460-12 | 14mm X 23mm X 60mm X 12° | In distribution |
| 31-32-1640-12 | 16mm X 18mm X 40mm X 12° | Withdrawn |
| 31-30-1440 | 14mm X 18mm X 40mm | Withdrawn |
| 31-23-0840-10 | 8mm x 23mm x 40mm x 10° | Withdrawn |
| 31-25-1640-12 | 16mm X 23mm X 40mm X 12° | Withdrawn |
| 31-30-1640 | 16mm X 18mm X 40mm | Withdrawn |
| 31-31-1640-12 | 16mm X 18mm X 40mm X 12° | 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.