Corbel
CORBEL Spacers are integrated anterior lumbar interbody fusion devices used to provide structural stability after discectomy. The filing says the spacers are available in different heights…
CORBEL Spacers are integrated anterior lumbar interbody fusion devices used to provide structural stability after discectomy. The filing says the spacers are available in different heights and geometric options to fit patient anatomy, with surface protrusions that grip adjacent vertebral endplates.
The devices are indicated at one or more lumbosacral levels from L1 to S1 as an adjunct to fusion. The filing describes use with screws or anchors, supplemental fixation, and a limited stand-alone configuration using three screws per implant under specified conditions.
Listed Item
Triple Barrel Anchor Guide, 15°, 11mm
Graft and Fixation
The spacers use autograft and/or allogenic bone graft. The filing specifies at least six months of non-operative treatment and distinguishes the general supplemental-fixation use from selected stand-alone cases.
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) | K201087 |
| Record published | 2021-04-02 |
| 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 |
|---|---|---|
| 1198.1019 | In distribution | |
| 6198.0010 | In distribution | |
| 1198.1121 | In distribution | |
| 1198.1217 | In distribution | |
| 1198.1119 | In distribution | |
| 1198.0417 | In distribution | |
| 1198.0421 | In distribution | |
| 1198.0919 | In distribution | |
| 1198.0921 | In distribution | |
| 1198.1017 | In distribution | |
| 1198.1421 | In distribution | |
| 6198.0011 | In distribution | |
| 1198.0315 | In distribution | |
| 1198.0617 | In distribution | |
| 1198.0717 | In distribution | |
| 1198.1319 | In distribution | |
| 1198.0719 | In distribution | |
| 1198.0317 | In distribution | |
| 1198.1021 | In distribution | |
| 1198.1221 | In distribution | |
| 1198.0419 | In distribution | |
| 1198.0713 | In distribution | |
| 1198.0213 | 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.