Monument
MONUMENT Spacer, Medium, 15deg, 13mm
3manufacturers in China registered for this device type
23catalogue 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) | K132559 |
| Record published | 2015-10-30 |
| 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 | Depth 25 to 29 mm; height 11 to 17 mm; width 31 to 39 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 3108.0513 | Depth 26 mm | In distribution |
| 3108.0817 | Width 39 mm | In distribution |
| 3108.0213 | Depth 25 mm | In distribution |
| 3108.0415 | Height 15 mm | In distribution |
| 3108.0717 | Width 39 mm | In distribution |
| 3108.0815 | Width 39 mm | In distribution |
| 3108.0117 | Lordosis 8 Degree | In distribution |
| 3108.0111 | Height 11 mm | In distribution |
| 3108.0211 | Lordosis 15 Degree | In distribution |
| 3108.0813 | Height 13 mm | In distribution |
| 3108.0511 | Depth 26 mm | In distribution |
| 3108.0517 | Width 34 mm | In distribution |
| 3108.0113 | Lordosis 8 Degree | In distribution |
| 3108.0417 | Width 34 mm | In distribution |
| 3108.0217 | Width 31 mm | In distribution |
| 3108.0215 | Depth 25 mm | In distribution |
| 3108.0413 | Lordosis 8 Degree | In distribution |
| 3108.0115 | Lordosis 8 Degree | In distribution |
| 3108.0715 | Width 39 mm | In distribution |
| 3108.0713 | Depth 29 mm | In distribution |
| 3108.0411 | Height 11 mm | In distribution |
| 3108.0515 | Lordosis 15 Degree | In distribution |
| 3108.0711 | Height 11 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.