Honour™ Spacer System
Straight Lumbar Spacer Aggressive, 30mm L x 10mm W x 15mm H
3manufacturers in China registered for this device type
158catalogue 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 | Nexxt Spine LLC, United States |
|---|---|
| FDA product code | MQP |
| Device type | Spinal Vertebral Body Replacement Device |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| Establishment | Contract manufacturer, Complaint-file establishment, Manufacturer |
| 510(k) | K120345 |
| Record published | 2015-07-29 |
| Record revised | 2021-06-09 (version 5) |
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 |
| Sizes | Height 5 to 18 mm; width 9 to 18 mm; depth 12 to 36 mm; length 22 to 250 mm; angle 0 to 10 °; outer diameter 8 mm |
| Distribution end date | 2021-09-24 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 35-1214-130 | Height 13 mm | In distribution |
| 21-269-10 | Length 26 mm | In distribution |
| 35-1214-050 | Height 5 mm | In distribution |
| 35-1618-075 | Height 7.5 mm | In distribution |
| I15-1033-11L | Lordotic | In distribution |
| 16-2810-13P | Length 28 mm | In distribution |
| 35-1416-170 | Height 17 mm | In distribution |
| 35-1212-070 | Height 7 mm | In distribution |
| I15-1033-15L | Lordotic | In distribution |
| 21-229-10 | Length 22 mm | In distribution |
| 16-3110-08P | Length 31 mm | In distribution |
| 35-1618-080 | Height 8 mm | In distribution |
| I35-10M-08-0 | Height 8 mm | In distribution |
| 16-3110-15L | Length 31 mm | In distribution |
| 21-2810-12 | Length 28 mm | In distribution |
| I15-1030-06L | Lordotic | In distribution |
| 35-1618-100 | Height 10 mm | In distribution |
| I15-1027-06L | Lordotic | In distribution |
| 16-2810-10L | Length 28 mm | In distribution |
| 21-269-16 | Length 26 mm | In distribution |
| I15-1033-13L | Lordotic | In distribution |
| 35-1416-110-10 | Height 11 mm | In distribution |
| I15-1036-09L | Lordotic | In distribution |
| 35-1212-050 | Height 5 mm | In distribution |
| 16-1030-09L | Length 30 mm | In distribution |
| 35-1416-060-0 | Angle 0 ° | In distribution |
| 21-269-06 | Length 26 mm | In distribution |
| 35-1618-140 | Height 14 mm | In distribution |
| 16-3110-12P | Length 31 mm | In distribution |
| 15-1036-14L | Length 36 mm | In distribution |
| 35-1214-065-10 | Height 6.5 mm | In distribution |
| 35-1618-070 | Height 7 mm | In distribution |
| 21-269-08 | Length 26 mm | In distribution |
| 35-1214-110-10 | Height 11 mm | In distribution |
| 35-1416-070-0 | Angle 0 ° | In distribution |
| 35-1416-150 | Height 15 mm | In distribution |
| 21-229-08 | Length 22 mm | In distribution |
| I35-10XM-09 | Depth 16 mm | In distribution |
| 35-1212-100 | Height 10 mm | In distribution |
| 35-1214-100-0 | Angle 0 ° | In distribution |
| 15-1036-16L | Length 36 mm | In distribution |
| I15-1027-08L | Lordotic | In distribution |
| 35-1618-120-10 | Height 12 mm | In distribution |
| 35-1416-100-0 | Angle 0 ° | In distribution |
| I15-1036-11L | Lordotic | In distribution |
| 15-1036-06L | Length 36 mm | In distribution |
| 16-3410-08L | Length 34 mm | In distribution |
| 16-1030-08L | Length 30 mm | In distribution |
| 16-2810-12L | Length 28 mm | In distribution |
| 21-269-12 | Length 26 mm | In distribution |
| 16-2810-11P | Length 28 mm | In distribution |
| 35-1212-110 | Height 11 mm | In distribution |
| 21-2810-16 | Length 28 mm | In distribution |
| I35-10M-14-0 | Height 14 mm | In distribution |
| 21-2810-06 | Length 28 mm | In distribution |
| 15-1036-12L | Length 36 mm | In distribution |
| 35-1214-150 | Height 15 mm | In distribution |
| 35-1212-090 | Height 9 mm | In distribution |
| 21-229-12 | Length 22 mm | In distribution |
| 16-1030-14L | Length 30 mm | In distribution |
| 35-1618-065 | Height 6.5 mm | In distribution |
| 21-2810-08 | Length 28 mm | In distribution |
| I15-1027-12L | Lordotic | In distribution |
| 16-3110-11L | Length 31 mm | In distribution |
| 35-1214-170 | Height 17 mm | In distribution |
| 16-1030-10L | Length 30 mm | In distribution |
| 35-1416-065 | Height 6.5 mm | In distribution |
| I15-1033-09L | Lordotic | In distribution |
| 16-3110-07L | Length 31 mm | In distribution |
| 35-1416-110 | Height 11 mm | In distribution |
| 16-2810-09P | Length 28 mm | In distribution |
| 21-3010-06 | Length 30 mm | In distribution |
| 15-1030-17L | Length 30 mm | In distribution |
| 35-1214-090 | Height 9 mm | In distribution |
| 21-2810-10 | Length 28 mm | In distribution |
| 35-1214-060-0 | Angle 0 ° | In distribution |
| 35-1214-110 | Height 11 mm | In distribution |
| 35-1212-080 | Height 8 mm | In distribution |
| 15-1030-15P | Length 30 mm | In distribution |
| 21-3010-08 | Length 30 mm | In distribution |
| 16-1030-11L | Length 30 mm | In distribution |
| I15-1036-13L | Lordotic | In distribution |
| 16-2810-16L | Length 28 mm | In distribution |
| 21-3010-16 | Length 30 mm | In distribution |
| 35-1618-180 | Height 18 mm | In distribution |
| 16-1030-07L | Length 30 mm | In distribution |
| 21-229-06 | Length 22 mm | In distribution |
| 16-2810-07P | Length 28 mm | In distribution |
| 16-3110-10P | Length 31 mm | In distribution |
| 35-1214-050-10 | Height 5 mm | In distribution |
| 21-2810-14 | Length 28 mm | In distribution |
| I35-10XM-07 | Depth 16 mm | In distribution |
| 16-2810-15P | Length 28 mm | In distribution |
| 35-1416-080-0 | Angle 0 ° | In distribution |
| 15-1036-10L | Length 36 mm | In distribution |
| 35-1212-060 | Height 6 mm | In distribution |
| 21-3010-10 | Length 30 mm | In distribution |
| 35-1416-075-10 | Height 7.5 mm | In distribution |
| 35-1214-065 | Height 6.5 mm | In distribution |
| I35-10S-11-10-NS | Angle 10 ° | In distribution |
| 35-1214-075 | Height 7.5 mm | In distribution |
| 35-1214-080-0 | Angle 0 ° | In distribution |
| 35-1618-110 | Height 11 mm | In distribution |
| I15-1027-14L | Lordotic | In distribution |
| 21-229-16 | Length 22 mm | In distribution |
| I15-1033-07L | Lordotic | In distribution |
| 21-229-14 | Length 22 mm | In distribution |
| 16-3110-14P | Length 31 mm | In distribution |
| 35-1214-090-10 | Height 9 mm | In distribution |
| 35-1416-130 | Height 13 mm | In distribution |
| 35-1416-065-10 | Height 6.5 mm | In distribution |
| 16-3110-09L | Length 31 mm | In distribution |
| 35-1212-075 | Height 7.5 mm | In distribution |
| I15-1027-10L | Lordotic | In distribution |
| 35-1416-090-10 | Height 9 mm | In distribution |
| 35-1416-050 | Height 5 mm | In distribution |
| 21-269-14 | Length 26 mm | In distribution |
| 21-3010-12 | Length 30 mm | In distribution |
| I15-1036-07L | Lordotic | In distribution |
| 16-3110-13L | Length 31 mm | In distribution |
| 35-1618-130 | Height 13 mm | In distribution |
| 15-1030-17P | Length 30 mm | In distribution |
| 35-1214-070-0 | Angle 0 ° | In distribution |
| 16-1030-12L | Length 30 mm | In distribution |
| 21-3010-14 | Length 30 mm | In distribution |
| 35-1214-075-10 | Height 7.5 mm | In distribution |
| I15-1036-15L | Lordotic | In distribution |
| 35-1416-050-10 | Height 5 mm | In distribution |
| I35-10M-12-0 | Height 12 mm | In distribution |
| 16-2810-14L | Length 28 mm | In distribution |
| 35-1212-065 | Height 6.5 mm | In distribution |
| 15-1036-08L | Length 36 mm | In distribution |
| 35-1416-090 | Height 9 mm | In distribution |
| 15-1030-15L | Length 30 mm | In distribution |
| I21-01-02 | In distribution | |
| 16-1030-13L | Length 30 mm | In distribution |
| 35-1618-060 | Height 6 mm | In distribution |
| 35-1618-050 | Height 5 mm | In distribution |
| 35-1416-075 | Height 7.5 mm | In distribution |
| 35-1618-090 | Height 9 mm | In distribution |
| I35-10M-10-0 | Height 10 mm | In distribution |
| 16-2810-08L | Length 28 mm | In distribution |
| 22-269-15 | Length 26 mm | Withdrawn |
| 22-269-17 | Length 26 mm | Withdrawn |
| 22-229-11 | Length 22 mm | Withdrawn |
| 22-269-13 | Length 26 mm | Withdrawn |
| I15-01-02 | Length 250 mm | Withdrawn |
| 22-229-13 | Length 22 mm | Withdrawn |
| 22-269-09 | Length 26 mm | Withdrawn |
| 22-229-09 | Length 22 mm | Withdrawn |
| 22-3010-15 | Length 30 mm | Withdrawn |
| 22-269-11 | Length 26 mm | Withdrawn |
| 22-229-17 | Length 22 mm | Withdrawn |
| 22-3010-17 | Length 30 mm | Withdrawn |
| 22-229-15 | Length 22 mm | Withdrawn |
| 22-3010-11 | Length 30 mm | Withdrawn |
| 22-3010-09 | Length 30 mm | Withdrawn |
| 22-3010-13 | Length 30 mm | 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
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.