PEEK Interbody Fusion System
25x9, 13mm, 5degree PLIF PEEK Interbody Spacer
3manufacturers in China registered for this device type
32catalogue numbers in this listing
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 | Altus Spine, United States |
|---|---|
| FDA product code | MQP |
| Device type | Spinal Vertebral Body Replacement Device |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| Record published | 2017-08-22 |
| Record revised | 2020-02-24 (version 3) |
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, manufacturing date |
| Sizes | Height 5 to 13 mm; length 22 to 28 mm; width 9 to 11 mm; angle 5 ° |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TL006 | Height 6 mm | In distribution |
| TL22009 | Width 11 mm | In distribution |
| TL22007 | Width 11 mm | In distribution |
| PL008 | Length 25 mm | In distribution |
| TL005 | Width 11 mm | In distribution |
| PL513 | Length 25 mm | In distribution |
| TL007 | Height 7 mm | In distribution |
| TL22011 | Length 22 mm | In distribution |
| PL508 | Length 25 mm | In distribution |
| TL22005 | Length 22 mm | In distribution |
| PL510 | Height 10 mm | In distribution |
| PL512 | Length 25 mm | In distribution |
| PL511 | Height 11 mm | In distribution |
| PL509 | Width 9 mm | In distribution |
| TL010 | Length 28 mm | In distribution |
| TL013 | Height 13 mm | In distribution |
| PL009 | Width 9 mm | In distribution |
| TL011 | Height 11 mm | In distribution |
| PL013 | Width 9 mm | In distribution |
| TL012 | Height 12 mm | In distribution |
| PL010 | Width 9 mm | In distribution |
| PL007 | Width 9 mm | In distribution |
| TL22013 | Length 22 mm | In distribution |
| PL012 | Length 25 mm | In distribution |
| TL22008 | Width 11 mm | In distribution |
| TL22010 | Width 11 mm | In distribution |
| TL22012 | Width 11 mm | In distribution |
| TL008 | Width 11 mm | In distribution |
| PL507 | Angle 5 ° | In distribution |
| PL011 | Width 9 mm | In distribution |
| TL009 | Length 28 mm | In distribution |
| TL22006 | Width 11 mm | 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
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.