Opal
Opal Spacer 10MM X 28MM 13MM Height-Revolve
3manufacturers in China registered for this device type
29catalogue numbers in this listing
1510(k) clearance
1recall
Who Else Makes It
Concentrated in Shanghai (1), Jiangsu (1), Shandong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
Record
| Listed by | Synthes Gmbh, Switzerland |
|---|---|
| FDA product code | MQP |
| Device type | Spinal Vertebral Body Replacement Device |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| Establishment | Specification developer, Manufacturer, Exporter |
| 510(k) | K072791 |
| Record published | 2015-09-14 |
| Record revised | 2026-05-11 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SD08.803.214 | In distribution | |
| 08.803.111 | In distribution | |
| 08.803.230 | In distribution | |
| 08.803.133 | In distribution | |
| SD08.803.114 | In distribution | |
| 08.803.051 | In distribution | |
| 08.803.209 | In distribution | |
| 08.803.210 | In distribution | |
| 08.803.108 | In distribution | |
| 08.803.216 | In distribution | |
| 08.803.112 | In distribution | |
| 08.803.132 | In distribution | |
| 08.803.117 | In distribution | |
| 08.803.050 | In distribution | |
| 08.803.217 | In distribution | |
| 08.803.114 | In distribution | |
| 08.803.131 | In distribution | |
| 08.803.234 | In distribution | |
| 08.803.235 | In distribution | |
| 08.803.052 | In distribution | |
| SD08.803.116 | In distribution | |
| 08.803.055 | In distribution | |
| 08.803.130 | In distribution | |
| SD08.803.134 | In distribution | |
| 08.803.231 | In distribution | |
| 08.803.134 | In distribution | |
| 08.803.135 | In distribution | |
| 08.803.113 | In distribution | |
| 08.803.213 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CoRoent | Nuvasive, Inc. | 1,514 |
| Capri™ Corpectomy Cage System | VB Spine LLC | 1,509 |
| Aleutian® Interbody Systems | VB Spine LLC | 1,189 |
| Fortify | Globus Medical, Inc. | 866 |
| Matrixx System | Nexxt Spine LLC | 748 |
| Ascend | Alphatec Spine, Inc. | 555 |
| Zavation VBR Trial | Zavation | 548 |
| Verte-Stack® Spinal System | Medtronic Sofamor Danek, Inc. | 484 |
| Timberline® Lateral Interbody Fusion System | Biomet Spine | 470 |
| Timberline Lateral Fusion System | Biomet Spine | 459 |
| Novel | Alphatec Spine, Inc. | 447 |
| Hawkeye™ Vertebral Body Replacement (VBR) | Choice Spine, LP | 368 |
Showing 12 of 683. All products under Spinal Vertebral Body Replacement Device
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K003836 | 2001-05-29 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Synthes (USA) Products LLC | 510(k) number | 2016-02-18 | Class II | Labeling mix-ups | The label on the outer packaging does not match the product inside and intended use of the device. | 6 units | 2016-11-08 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2014-04-08 | Class II | Process control | Two lots of the Synthes XRL Medium Trial-Central Body device were incorrectly etched with the incorrect dimensions for height. | 3 | 2015-09-10 |
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.