MectaLIF Anterior
MectaLIF Ant. – Single Lead Lag Screw Dia. 5.5x30 (1x)
3manufacturers in China registered for this device type
153catalogue 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) | K221545 |
| Record published | 2022-10-27 |
| Record revised | 2024-09-11 (version 4) |
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
| Catalogue number | Size | Status |
|---|---|---|
| 03.31.078 | In distribution | |
| 03.31.087 | In distribution | |
| 03.31.070 | In distribution | |
| 03.31.063 | In distribution | |
| 03.31.515 | In distribution | |
| 03.31.074 | In distribution | |
| 03.31.052 | In distribution | |
| 03.31.082 | In distribution | |
| 03.31.053 | In distribution | |
| 03.31.563 | In distribution | |
| 03.30.301 | In distribution | |
| 03.31.049 | In distribution | |
| 03.30.302 | In distribution | |
| 03.30.162 | In distribution | |
| 03.31.084 | In distribution | |
| 03.31.523 | In distribution | |
| 03.30.183 | In distribution | |
| 03.31.541 | In distribution | |
| 03.31.091 | In distribution | |
| 03.31.508 | In distribution | |
| 03.31.556 | In distribution | |
| 03.31.062 | In distribution | |
| 03.31.045 | In distribution | |
| 03.31.531 | In distribution | |
| 03.30.184 | In distribution | |
| 03.30.166 | In distribution | |
| 03.30.300 | In distribution | |
| 03.31.527 | In distribution | |
| 03.31.544 | In distribution | |
| 03.31.543 | In distribution | |
| 03.30.403 | In distribution | |
| 03.31.536 | In distribution | |
| 03.31.042 | In distribution | |
| 03.31.555 | In distribution | |
| 03.31.072 | In distribution | |
| 03.31.086 | In distribution | |
| 03.31.511 | In distribution | |
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| 03.30.178 | In distribution | |
| 03.30.303 | In distribution | |
| 03.30.191 | In distribution | |
| 03.31.076 | In distribution | |
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| 03.30.400 | In distribution | |
| 03.30.402 | In distribution | |
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| 03.31.516 | In distribution | |
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| 03.31.056 | In distribution | |
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| 03.31.528 | In distribution | |
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| 03.30.171 | In distribution | |
| 03.31.040 | In distribution | |
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| 03.31.552 | In distribution | |
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| 03.31.526 | In distribution | |
| 03.30.304 | In distribution | |
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| 03.31.525 | In distribution | |
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| 03.30.197 | In distribution | |
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| 03.30.198 | In distribution | |
| 03.31.061 | In distribution | |
| 03.31.513 | In distribution | |
| 03.31.551 | In distribution | |
| 03.31.533 | In distribution | |
| 03.31.510 | In distribution | |
| 03.30.175 | In distribution | |
| 03.31.090 | In distribution | |
| 03.30.181 | 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 |
|---|---|
| K160605 | 2016-07-21 |
| K124034 | 2013-05-17 |
Recalls Naming This Product
6 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 |
|---|---|---|---|---|---|---|
| Medacta Usa Inc | 510(k) number | 2023-03-08 | Class II | Under Investigation by firm | There is a potential for breakage of the small screw used to affix the anti-backout plate. | 32 units |
| Medacta Usa Inc | 510(k) number | 2023-03-08 | Class II | Under Investigation by firm | There is a potential for breakage of the small screw used to affix the anti-backout plate. | 53 units |
| Medacta Usa Inc | 510(k) number | 2023-03-08 | Class II | Under Investigation by firm | There is a potential for breakage of the small screw used to affix the anti-backout plate. | 44 units |
| Medacta Usa Inc | 510(k) number | 2023-03-08 | Class II | Under Investigation by firm | There is a potential for breakage of the small screw used to affix the anti-backout plate. | 34 units |
| Medacta Usa Inc | 510(k) number | 2023-03-08 | Class II | Under Investigation by firm | There is a potential for breakage of the small screw used to affix the anti-backout plate. | 17 unis |
| Medacta Usa Inc | 510(k) number | 2023-03-08 | Class II | Under Investigation by firm | There is a potential for breakage of the small screw used to affix the anti-backout plate. | 50 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.