Spira®-A Integrated
SPIRA®-A Integrated, 30x42mm, 30° Lordotic, 23mm
3manufacturers in China registered for this device type
68catalogue numbers in this listing
3510(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 | Camber Spine Technologies, 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, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K234077 |
| Record published | 2024-12-17 |
| Record revised | 2025-07-14 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SAZ-3042-3023 | In distribution | |
| SAZ-2634-0811 | In distribution | |
| SAZ-2838-2015 | In distribution | |
| SAZ-2634-1513 | In distribution | |
| SAZ-3042-3021 | In distribution | |
| SAZ-3042-0811 | In distribution | |
| SAZ-3042-0815 | In distribution | |
| SAZ-2838-0815 | In distribution | |
| SAZ-2634-1511 | In distribution | |
| SAZ-3042-0813 | In distribution | |
| SAZ-2838-2019 | In distribution | |
| SAZ-2634-1519 | In distribution | |
| SAZ-2838-1513 | In distribution | |
| SAZ-3042-0819 | In distribution | |
| SAZ-2634-1517 | In distribution | |
| SAZ-2838-1515 | In distribution | |
| SAZ-3042-1511 | In distribution | |
| SAZ-3042-2517 | In distribution | |
| SAZ-2838-2519 | In distribution | |
| SAZ-2838-2517 | In distribution | |
| SAZ-2838-1521 | In distribution | |
| SAZ-2634-0819 | In distribution | |
| SAZ-2634-3019 | In distribution | |
| SAZ-2634-0809 | In distribution | |
| SAZ-2838-1511 | In distribution | |
| SAZ-3042-2021 | In distribution | |
| SAZ-2634-2521 | In distribution | |
| SAZ-2838-0817 | In distribution | |
| SAZ-2634-2519 | In distribution | |
| SAZ-3042-1513 | In distribution | |
| SAZ-2838-2021 | In distribution | |
| SAZ-3042-2519 | In distribution | |
| SAZ-2838-3021 | In distribution | |
| SAZ-3042-0809 | In distribution | |
| SAZ-3042-2019 | In distribution | |
| SAZ-2838-2521 | In distribution | |
| SAZ-3042-2015 | In distribution | |
| SAZ-2634-2013 | In distribution | |
| SAZ-2634-2517 | In distribution | |
| SAZ-2838-0819 | In distribution | |
| SAZ-2838-2013 | In distribution | |
| SAZ-2634-2019 | In distribution | |
| SAZ-3042-1519 | In distribution | |
| SAZ-3042-2017 | In distribution | |
| SAZ-2838-1519 | In distribution | |
| SAZ-2838-0821 | In distribution | |
| SAZ-2838-0809 | In distribution | |
| SAZ-2634-3017 | In distribution | |
| SAZ-2634-2515 | In distribution | |
| SAZ-2634-3021 | In distribution | |
| SAZ-3042-1517 | In distribution | |
| SAZ-3042-0821 | In distribution | |
| SAZ-3042-2521 | In distribution | |
| SAZ-2634-2015 | In distribution | |
| SAZ-2634-0817 | In distribution | |
| SAZ-2634-0813 | In distribution | |
| SAZ-2634-2021 | In distribution | |
| SAZ-3042-0817 | In distribution | |
| SAZ-2838-2017 | In distribution | |
| SAZ-2838-3019 | In distribution | |
| SAZ-2838-0811 | In distribution | |
| SAZ-2838-0813 | In distribution | |
| SAZ-2838-1517 | In distribution | |
| SAZ-2634-1515 | In distribution | |
| SAZ-2634-1521 | In distribution | |
| SAZ-2634-2017 | In distribution | |
| SAZ-2634-0821 | In distribution | |
| SAZ-3042-1515 | 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 |
|---|---|
| K221324 | 2023-03-30 |
| K173432 | 2018-04-18 |
| K153720 | 2016-05-03 |
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.