Catalyft™ LS Expandable Interbody System
Screw 981304555 4.5 X 55MM Single Lead
3manufacturers in China registered for this device type
17catalogue 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 | Medtronic Sofamor Danek, 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 |
| 510(k) | K241992 |
| Record published | 2024-12-16 |
| Record revised | 2024-09-11 (version 2) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 981304555 | In distribution | |
| 981304545 | In distribution | |
| 981305050 | In distribution | |
| 981305055 | In distribution | |
| 981305040 | In distribution | |
| 981304540 | In distribution | |
| 981304535 | In distribution | |
| 981305035 | In distribution | |
| 981304520 | In distribution | |
| 981304550 | In distribution | |
| 981305045 | In distribution | |
| 981305025 | In distribution | |
| 981305020 | In distribution | |
| 981304530 | In distribution | |
| 981000006 | In distribution | |
| 981305030 | In distribution | |
| 981304525 | 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 |
|---|---|
| K121982 | 2012-07-26 |
| K110063 | 2011-10-04 |
| K091813 | 2009-11-17 |
Recalls Naming This Product
7 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Medtronic Sofamor Danek USA, Inc. | 510(k) number | 2023-06-06 | Class II | Under Investigation by firm | There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices can be inserted between two lumbar or lumbosacral vertebral bodies to give suppo | 34 units |
| Medtronic Sofamor Danek USA, Inc. | 510(k) number | 2023-06-06 | Class II | Under Investigation by firm | There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices can be inserted between two lumbar or lumbosacral vertebral bodies to give suppo | 8 units |
| Medtronic Sofamor Danek USA, Inc. | 510(k) number | 2023-06-06 | Class II | Under Investigation by firm | There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices can be inserted between two lumbar or lumbosacral vertebral bodies to give suppo | 25 units |
| Medtronic Sofamor Danek USA, Inc. | 510(k) number | 2023-06-06 | Class II | Under Investigation by firm | There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices can be inserted between two lumbar or lumbosacral vertebral bodies to give suppo | 11 units |
| Medtronic Sofamor Danek USA, Inc. | 510(k) number | 2023-06-06 | Class II | Under Investigation by firm | There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices can be inserted between two lumbar or lumbosacral vertebral bodies to give suppo | 10 units |
| Medtronic Sofamor Danek USA, Inc. | 510(k) number | 2023-06-06 | Class II | Under Investigation by firm | There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices can be inserted between two lumbar or lumbosacral vertebral bodies to give suppo | 8 units |
| Medtronic Sofamor Danek USA, Inc. | 510(k) number | 2023-06-06 | Class II | Under Investigation by firm | There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices can be inserted between two lumbar or lumbosacral vertebral bodies to give suppo | 12 units |
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.