MectaLIF Anterior System
MectaLIF Anterior is a lumbar interbody fusion system that combines a disc spacer, a plate and bone screws. The spacer holds bone graft between adjacent vertebrae, while the plate and…
MectaLIF Anterior is a lumbar interbody fusion system that combines a disc spacer, a plate and bone screws. The spacer holds bone graft between adjacent vertebrae, while the plate and screws secure the assembly to the vertebral bodies.
A PEEK-OPTIMA spacer with three tantalum markers is one configuration within the range. Its titanium alloy plate interlocks with the spacer, and titanium alloy bone screws secure the two components to bone.
Listed Item
Anterior Interbody Fusion Device 24x31x18 L20° – TiPeek
Plate Configurations
Flush and Long plate designs use four bone screws, while the L5-S1 design uses three. The integrated plate-and-screw assembly is used with additional supplemental fixation, such as pedicle screws and rods.
3manufacturers in China registered for this device type
148catalogue 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 | Medacta International SA, Switzerland |
|---|---|
| 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, Private-label distributor, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K124034 |
| Record published | 2014-11-18 |
| Record revised | 2024-09-11 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
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|---|---|---|
| 03.30.105 | In distribution | |
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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 |
|---|---|
| K160605 | 2016-07-21 |
| K124034 | 2013-05-17 |
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.