Elsa
ELSA Spacer 20 x 65mm, 11-20mm, 15-30°
3manufacturers in China registered for this device type
18catalogue 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) | K161379 |
| Record published | 2021-01-24 |
| Record revised | 2025-07-14 (version 2) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1122.0160 | In distribution | |
| 1122.0140 | In distribution | |
| 1122.0455 | In distribution | |
| 1122.0450 | In distribution | |
| 1122.0445 | In distribution | |
| 6219.1000 | In distribution | |
| 1122.0150 | In distribution | |
| 1122.0465 | In distribution | |
| 1122.2065 | In distribution | |
| 1122.0145 | In distribution | |
| 1122.2040 | In distribution | |
| 1122.1055 | In distribution | |
| 1122.0460 | In distribution | |
| 1122.1050 | In distribution | |
| 1122.2060 | In distribution | |
| 1122.2045 | In distribution | |
| 1122.0055 | In distribution | |
| 1122.0050 | 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.