ROI-A
ROI-A Median Implant PXL 23X26 H14 10°
3manufacturers in China registered for this device type
34catalogue numbers in this listing
8510(k) clearances naming this product code
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 | Ldr Spine USA, United States |
|---|---|
| FDA product code | MQP |
| Device type | Spinal Vertebral Body Replacement Device |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| Record published | 2015-10-24 |
| Record revised | 2025-01-03 (version 5) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Sizes | Angle 2 to 14 °; width 26 to 36 mm; depth 23 to 33 mm; height 9 to 19 mm |
| Distribution end date | 2016-02-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IR2009T | In distribution | |
| IR2521P | Angle 6 ° | In distribution |
| IR2435P | Angle 10 ° | In distribution |
| IR2422P | Angle 6 ° | In distribution |
| IR2516P | Angle 2 ° | In distribution |
| IR2421P | Angle 2 ° | In distribution |
| IR2442P | Angle 14 ° | In distribution |
| IR2433P | Angle 10 ° | In distribution |
| IR2443P | Angle 14 ° | In distribution |
| IR2523P | Angle 6 ° | In distribution |
| IR2426P | Angle 6 ° | In distribution |
| IR2512P | Angle 2 ° | In distribution |
| IR2511P | Angle 2 ° | In distribution |
| IR2531P | Angle 10 ° | In distribution |
| IR2524P | Angle 6 ° | In distribution |
| IR2615P | Angle 2 ° | In distribution |
| IR2541P | Angle 14 ° | In distribution |
| IR2728P | Angle 6 ° | In distribution |
| IR2007T | In distribution | |
| IR2646P | Angle 14 ° | In distribution |
| IR2441P | Angle 14 ° | In distribution |
| IR2431P | Angle 10 ° | In distribution |
| IR2522P | Angle 6 ° | In distribution |
| IR2525P | Angle 6 ° | In distribution |
| IR2721P | Angle 6 ° | In distribution |
| IR2742P | Angle 10 ° | In distribution |
| IR2008T | In distribution | |
| IR2424P | Angle 6 ° | In distribution |
| IR2514P | Angle 2 ° | In distribution |
| IR2735P | Angle 10 ° | In distribution |
| IR2423P | Angle 6 ° | In distribution |
| IR2527P | Angle 6 ° | In distribution |
| IR2513P | Angle 2 ° | In distribution |
| IR2003T | Withdrawn |
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 |
|---|---|
| K162133 | 2017-05-16 |
| K083857 | 2009-02-12 |
| K080728 | 2008-05-29 |
| K080569 | 2008-05-07 |
| K080572 | 2008-04-07 |
| K072132 | 2007-08-30 |
| K043479 | 2005-06-30 |
| K043349 | 2005-06-29 |
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.