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MAGNIFY-S, Standalone Expandable ALIF Spacer, 26 x 34mm, 20°, 18-21mm
3manufacturers in China registered for this device type
26catalogue numbers in this listing
11510(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 | Globus Medical, 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 | Manufacturer, Exporter |
| 510(k) | K142498 |
| Record published | 2016-01-19 |
| Record revised | 2025-07-14 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Label carries | lot or batch number |
| Sizes | Height 8 to 18 mm; width 31 to 39 mm; depth 25 to 29 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1126.1318 | Height 18 mm | In distribution |
| 1126.1108 | Height 8 mm | In distribution |
| 1126.0218 | Lordosis 15 Degree | In distribution |
| 1126.1316 | Depth 26 mm | In distribution |
| 1126.1110 | Width 34 mm | In distribution |
| 1126.2110 | Lordosis 8 Degree | In distribution |
| 1126.2116 | Lordosis 8 Degree | In distribution |
| 1126.2318 | Lordosis 20 Degree | In distribution |
| 1126.0316 | Depth 25 mm | In distribution |
| 1126.0318 | Width 31 mm | In distribution |
| 1126.2112 | Lordosis 8 Degree | In distribution |
| 1126.2212 | Width 39 mm | In distribution |
| 1126.1116 | Depth 26 mm | In distribution |
| 1126.0212 | Lordosis 15 Degree | In distribution |
| 1126.0312 | Width 31 mm | In distribution |
| 1126.1210 | Width 34 mm | In distribution |
| 1126.0112 | Height 12 mm | In distribution |
| 1126.2108 | Lordosis 8 Degree | In distribution |
| 1126.2118 | Depth 29 mm | In distribution |
| 1126.0118 | Lordosis 8 Degree | In distribution |
| 1126.0114 | Width 31 mm | In distribution |
| 1126.0216 | Height 16 mm | In distribution |
| 1126.1112 | Width 34 mm | In distribution |
| 1126.1212 | Height 12 mm | In distribution |
| 1126.0110 | Lordosis 8 Degree | In distribution |
| 1126.2210 | Height 10 mm | 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 |
|---|---|
| K253401 | 2026-04-29 |
| K201087 | 2020-07-31 |
| K170157 | 2017-09-25 |
| K161379 | 2016-09-29 |
| K160597 | 2016-08-29 |
| K161223 | 2016-07-15 |
| K142498 | 2015-02-26 |
| K132559 | 2013-12-30 |
| K120101 | 2012-03-27 |
| K103382 | 2011-05-20 |
| K082252 | 2008-11-05 |
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.