Alphatec Solus
ALPHATEC SOLUS LUMBAR SPACER, 14mm MEDIUM, 12° LORDOTIC, STERILE
3manufacturers in China registered for this device type
33catalogue numbers in this listing
5510(k) clearances naming this product code
1recall
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 | Alphatec Spine, Inc., 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) | K123993 |
| Record published | 2020-03-02 |
| Record revised | 2023-04-07 (version 5) |
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 |
| Distribution end date | 2023-04-06 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 25960-110 | Withdrawn | |
| 25600-314-S | Withdrawn | |
| 25940-116 | Withdrawn | |
| 25940-316 | Withdrawn | |
| 25200-314-S | Withdrawn | |
| 25200-114-S | Withdrawn | |
| 25960-316 | Withdrawn | |
| 25940-110 | Withdrawn | |
| 25600-318-S | Withdrawn | |
| 25960-312 | Withdrawn | |
| 25940-112 | Withdrawn | |
| 25200-316-S | Withdrawn | |
| 25200-112-S | Withdrawn | |
| 25200-312-S | Withdrawn | |
| 25940-114 | Withdrawn | |
| 25200-110-S | Withdrawn | |
| 25960-314 | Withdrawn | |
| 25600-112-S | Withdrawn | |
| 25960-118 | Withdrawn | |
| 25979 | Withdrawn | |
| 25972 | Withdrawn | |
| 25960-318 | Withdrawn | |
| 25600-312-S | Withdrawn | |
| 25910 | Withdrawn | |
| 25971 | Withdrawn | |
| 25960-116 | Withdrawn | |
| 25600-116-S | Withdrawn | |
| 25600-114-S | Withdrawn | |
| 25940-312 | Withdrawn | |
| 25960-114 | Withdrawn | |
| 25940-314 | Withdrawn | |
| 25960-112 | Withdrawn | |
| 25600-316-S | 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 |
|---|---|
| K251575 | 2025-09-03 |
| K232097 | 2023-09-25 |
| K203742 | 2021-04-09 |
| K123993 | 2013-03-05 |
| K102402 | 2011-03-30 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2024-01-26 | Class II | Device Design | Due to reports of intraoperative graft bolt implantation breakages. | 12,777 devices |
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.