Honour™ Spacer System
Honour cervical spacers are radiolucent PEEK interbody cages with tantalum marker pins. Their structural-column shape has open upper and lower surfaces and serrations that help stabilize…
Honour cervical spacers are radiolucent PEEK interbody cages with tantalum marker pins. Their structural-column shape has open upper and lower surfaces and serrations that help stabilize the implant between vertebrae.
Spacer height, length, width and anteroposterior angle vary to suit the anatomy. The cervical configuration uses autogenous bone graft and a separate supplemental cervical fixation system.
Listed Item
Cervical, Trial Drill Guide, Complete, 6°, 12x14x7mm
Cervical Configuration
The cervical indication is for a single level from C2 to T1 in skeletally mature patients after at least six weeks of nonoperative care. The wider Honour family also has lumbar and vertebral-replacement configurations, with different anatomical scopes and graft requirements.
7manufacturers in China registered for this device type
296catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Shanghai (2), Shandong (2), Zhejiang (2). 3 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 |
| Zhisu Health Tech Jiaxing Co., Ltd. | Tongxiang | Zhejiang | Contract manufacturer | 4 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
| Shanghai Sanyou Medical Co., Ltd. | Shanghai | Shanghai | Manufacturer | 6 |
Record
| Listed by | Nexxt Spine LLC, United States |
|---|---|
| FDA product code | ODP |
| Device type | Intervertebral Fusion Device With Bone Graft, Cervical |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Establishment | Contract manufacturer, Complaint-file establishment, Manufacturer |
| 510(k) | K120345 |
| Record published | 2016-09-25 |
| Record revised | 2023-04-04 (version 7) |
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, serial number |
| Sizes | Height 5 to 18 mm; width 9 to 18 mm; depth 12 to 34 mm; angle 0 to 10 °; length 5 to 34 mm |
| Distribution end date | 2022-03-18 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| I35-10M-05-0 | Angle 0 ° | In distribution |
| 21-3410-12 | Width 10 mm | In distribution |
| I21-229-17L | Height 17 mm | In distribution |
| I35-20M-05 | Angle 6 ° | In distribution |
| 21-3210-14 | Width 10 mm | In distribution |
| C16-02-04 | In distribution | |
| I35-10XL-12-10-NS | Angle 10 ° | In distribution |
| 35-1416-160-10 | Height 16 mm | In distribution |
| I35-10M-09-10-NS | No Stop | In distribution |
| I35-10S-07-10 | Angle 10 ° | In distribution |
| I21-269-09 | Detachable | In distribution |
| I35-20M-11-0-NS | No Stop | In distribution |
| I21-269-12L | Height 12 mm | In distribution |
| 35-1416-130-10 | Height 13 mm | In distribution |
| I21-3410-14 | Detachable | In distribution |
| I21-3210-17 | Detachable | In distribution |
| I35-10XL-11 | Angle 6 ° | In distribution |
| C35-03-14 | In distribution | |
| I35-10XL-12-10 | Angle 10 ° | In distribution |
| I35-10L-09-10 | Height 9 mm | In distribution |
| 35-1618-160 | Height 16 mm | In distribution |
| I35-10L-10-10-NS | Angle 10 ° | In distribution |
| I35-20M-09-0-NS | No Stop | In distribution |
| I35-10S-10-10-NS | No Stop | In distribution |
| I21-3010-16 | Detachable | In distribution |
| I35-20XM-08-NS | Angle 6 ° | In distribution |
| I21-3010-14 | Detachable | In distribution |
| I35-10S-08-0 | Angle 0 ° | In distribution |
| I35-10XL-13-NS | Angle 6 ° | In distribution |
| I21-229-10 | Detachable | In distribution |
| I35-10S-10-NS | Angle 6 ° | In distribution |
| 21-3210-11 | Height 11 mm | In distribution |
| 21-3210-10 | Height 10 mm | In distribution |
| I35-10S-07-0-NS | No Stop | In distribution |
| 16-3410-11P | Height 11 mm | In distribution |
| I21-3010-15L | Height 15 mm | In distribution |
| C35-03-02 | In distribution | |
| 35-1416-120-10 | Angle 10 ° | In distribution |
| I35-10M-11-NS | No Stop | In distribution |
| I35-10L-05-10 | Angle 10 ° | In distribution |
| 16-3410-13L | Height 13 mm | In distribution |
| I15-1030-11P | Depth 30 mm | In distribution |
| I15-1030-13L | Depth 30 mm | In distribution |
| I21-229-09L | Height 9 mm | In distribution |
| I35-10L-05-0-NS | No Stop | In distribution |
| I35-20L-10-10 | Angle 10 ° | In distribution |
| I35-20M-09 | Angle 6 ° | In distribution |
| 35-1416-140-10 | Height 14 mm | In distribution |
| 21-3210-13 | Height 13 mm | In distribution |
| I35-10M-10-0-NS | Angle 0 ° | In distribution |
| I35-10XM-05-NS | No Stop | In distribution |
| 35-1618-150 | Height 15 mm | In distribution |
| I35-20XM-09 | Angle 6 ° | In distribution |
| I35-30-01 | In distribution | |
| I21-3210-07 | Detachable | In distribution |
| I35-10XL-15 | Angle 6 ° | In distribution |
| I35-20S-09-NS | No Stop | In distribution |
| I35-10M-12 | Angle 6 ° | In distribution |
| I21-229-08 | Detachable | In distribution |
| I35-10L-09 | Angle 6 ° | In distribution |
| I21-2810-06 | Detachable | In distribution |
| I21-3210-11 | Detachable | In distribution |
| I35-10S-09-10 | Angle 10 ° | In distribution |
| I35-20S-05-0 | Angle 0 ° | In distribution |
| I21-3210-13 | Detachable | In distribution |
| C15-03-03 | In distribution | |
| I35-10M-09-NS | No Stop | In distribution |
| C16-02-07 | In distribution | |
| I21-3410-08 | Detachable | In distribution |
| C15-04-01 | In distribution | |
| I35-10XL-06-10 | Angle 10 ° | In distribution |
| I21-269-11 | Detachable | In distribution |
| I35-20L-07-0 | Angle 0 ° | In distribution |
| I35-20XM-06-NS | Angle 6 ° | In distribution |
| I15-1030-11L | Depth 30 mm | In distribution |
| I35-10L-06-10-NS | Angle 10 ° | In distribution |
| I35-10L-16-NS | Angle 6 ° | In distribution |
| I21-2810-14 | Detachable | In distribution |
| I21-269-16L | Height 16 mm | In distribution |
| I35-10XL-07 | Angle 6 ° | In distribution |
| I21-269-15 | Detachable | In distribution |
| I35-10XL-10-10-NS | Angle 10 ° | In distribution |
| 35-1416-180-10 | Height 18 mm | In distribution |
| I21-269-08L | Height 8 mm | In distribution |
| I35-20L-05-0 | Angle 0 ° | In distribution |
| I35-10S-05 | Angle 6 ° | In distribution |
| I35-10M-13-NS | No Stop | In distribution |
| I21-3010-06 | Detachable | In distribution |
| I21-229-15L | Height 15 mm | In distribution |
| I35-10S-09 | Angle 6 ° | In distribution |
| I35-20S-10-0-NS | Angle 0 ° | In distribution |
| C35-03-08 | In distribution | |
| I35-20M-09-10 | Angle 10 ° | In distribution |
| I35-20L-09-NS | No Stop | In distribution |
| I35-10L-17 | Angle 6 ° | In distribution |
| 21-3210-07 | Width 10 mm | In distribution |
| I35-10XL-09 | Angle 6 ° | In distribution |
| I35-10M-07-NS | No Stop | In distribution |
| I35-20L-06 | Angle 6 ° | In distribution |
| I35-20M-10-0 | Angle 0 ° | In distribution |
| 21-3410-08 | Width 10 mm | In distribution |
| I35-10M-11-10-NS | No Stop | In distribution |
| I35-20L-05-10-NS | No Stop | In distribution |
| I35-20S-08 | Angle 6 ° | In distribution |
| I21-229-11L | Height 11 mm | In distribution |
| I35-10M-06-0-NS | Angle 0 ° | In distribution |
| I35-20S-09-0 | Angle 0 ° | In distribution |
| I35-10M-08-0-NS | Angle 0 ° | In distribution |
| I35-20XM-07 | Angle 6 ° | In distribution |
| I21-3410-06 | Detachable | In distribution |
| I35-20M-08-NS | Angle 6 ° | In distribution |
| C15-01-01 | In distribution | |
| I35-20S-05-NS | No Stop | In distribution |
| I35-10L-12-10-NS | Angle 10 ° | In distribution |
| I35-10M-08 | Angle 6 ° | In distribution |
| I35-10M-07-10-NS | No Stop | In distribution |
| I35-10XL-06-10-NS | Angle 10 ° | In distribution |
| I35-20S-08-0-NS | Angle 0 ° | In distribution |
| C35-03-10 | In distribution | |
| I35-10L-15-10 | Height 15 mm | In distribution |
| I52-RU-05 | Angle 6 ° | In distribution |
| I35-10M-10 | Angle 6 ° | In distribution |
| I35-10M-06 | Angle 6 ° | In distribution |
| I35-10XL-14-10-NS | Angle 10 ° | In distribution |
| I21-3410-16 | Detachable | In distribution |
| I21-3010-17L | Height 17 mm | In distribution |
| C35-03-16 | In distribution | |
| I35-10L-08-10-NS | Angle 10 ° | In distribution |
| C21-03-07 | In distribution | |
| I35-20M-10-10-NS | Angle 10 ° | In distribution |
| I35-10M-14 | Angle 6 ° | In distribution |
| I35-20L-11-10-NS | No Stop | In distribution |
| I35-10L-09-0-NS | No Stop | In distribution |
| I35-20L-10-0-NS | Angle 0 ° | In distribution |
| I35-10M-17-NS | No Stop | In distribution |
| I21-3010-09L | Height 9 mm | In distribution |
| 16-3410-15L | Height 15 mm | In distribution |
| I35-10XM-07-NS | No Stop | In distribution |
| I35-10L-12-0 | Angle 0 ° | In distribution |
| I15-1030-15P | Depth 30 mm | In distribution |
| I21-269-13 | Detachable | In distribution |
| I35-20S-06 | Angle 6 ° | In distribution |
| I35-10M-18 | Angle 6 ° | In distribution |
| I35-20M-11-10 | Angle 10 ° | In distribution |
| I35-20XM-05 | Angle 6 ° | In distribution |
| I35-10L-06-0 | Angle 0 ° | In distribution |
| I35-10S-11-0-NS | No Stop | In distribution |
| I35-10XL-18-10 | Angle 10 ° | In distribution |
| I35-10L-14-10-NS | Angle 10 ° | In distribution |
| I35-10XL-17 | Angle 6 ° | In distribution |
| I35-10L-10-0 | Angle 0 ° | In distribution |
| C35-03-01 | In distribution | |
| I35-10S-05-0-NS | No Stop | In distribution |
| I21-269-10L | Height 10 mm | In distribution |
| I35-20S-06-0-NS | Angle 0 ° | In distribution |
| I35-10S-05-10-NS | Angle 10 ° | In distribution |
| I21-3010-07L | Height 7 mm | In distribution |
| I35-20L-08 | Angle 6 ° | In distribution |
| I35-10S-06-10 | Angle 10 ° | In distribution |
| I35-10M-15-NS | No Stop | In distribution |
| I35-10XM-09-NS | No Stop | In distribution |
| 16-3410-13P | Height 13 mm | In distribution |
| I35-10M-10-10 | Angle 10 ° | In distribution |
| I35-10S-09-0-NS | No Stop | In distribution |
| I35-20M-06-0 | Angle 0 ° | In distribution |
| I35-10S-09-10-NS | Angle 10 ° | In distribution |
| C16-02-01 | In distribution | |
| I35-10L-11-10 | Height 11 mm | In distribution |
| I35-10XL-08-10 | Angle 10 ° | In distribution |
| 21-3210-12 | Height 12 mm | In distribution |
| I21-3010-12 | Detachable | In distribution |
| I35-10XL-10-10 | Angle 10 ° | In distribution |
| I35-20M-10-NS | Angle 6 ° | In distribution |
| 16-3410-10P | Height 10 mm | In distribution |
| I15-1030-07P | Depth 30 mm | In distribution |
| I35-10XL-14-10 | Angle 10 ° | In distribution |
| I21-3010-13L | Height 13 mm | In distribution |
| I35-10M-08-10 | Angle 10 ° | In distribution |
| I35-20M-06-NS | Angle 6 ° | In distribution |
| I21-229-16 | Detachable | In distribution |
| I35-20S-07-NS | No Stop | In distribution |
| I35-10L-07-0-NS | No Stop | In distribution |
| C21-04-01 | In distribution | |
| I35-10XL-08-10-NS | Angle 10 ° | In distribution |
| C35-03-07 | In distribution | |
| I21-229-06 | Detachable | In distribution |
| I35-10L-10-NS | Angle 6 ° | In distribution |
| I35-20L-07-NS | No Stop | In distribution |
| I35-10S-11-10 | Angle 10 ° | In distribution |
| I35-10L-08-0 | Angle 0 ° | In distribution |
| I15-1030-09L | Depth 30 mm | In distribution |
| I21-2810-08 | Detachable | In distribution |
| I35-10L-08-NS | Angle 6 ° | In distribution |
| I21-229-07L | Height 7 mm | In distribution |
| I35-20L-06-0-NS | Angle 0 ° | In distribution |
| C16-02-05 | In distribution | |
| I35-10S-07-10-NS | Angle 10 ° | In distribution |
| I21-2810-16 | Detachable | In distribution |
| I35-20L-06-10 | Angle 10 ° | In distribution |
| 16-3410-08P | Height 8 mm | In distribution |
| I35-20M-07-10 | Angle 10 ° | In distribution |
| I35-10L-17-10 | Height 17 mm | In distribution |
| I35-20M-07 | Angle 6 ° | In distribution |
| 21-3410-16 | Width 10 mm | In distribution |
| I35-20M-05-10 | Angle 10 ° | In distribution |
| I35-10S-07 | Angle 6 ° | In distribution |
| I21-269-06L | Height 6 mm | In distribution |
| I35-10S-08-NS | Angle 6 ° | In distribution |
| I21-269-14L | Height 14 mm | In distribution |
| C21-02-01 | In distribution | |
| I35-10L-18-NS | Angle 6 ° | In distribution |
| I35-20L-11-0 | Angle 0 ° | In distribution |
| I35-10XL-13 | Angle 6 ° | In distribution |
| I35-10M-05-10-NS | No Stop | In distribution |
| I35-20L-09-10-NS | No Stop | In distribution |
| I21-3010-08 | Detachable | In distribution |
| I21-3410-10 | Detachable | In distribution |
| I35-20L-08-0-NS | Angle 0 ° | In distribution |
| C21-03-03 | In distribution | |
| I35-20M-11 | Angle 6 ° | In distribution |
| I35-20L-11-NS | No Stop | In distribution |
| I35-10M-16 | Angle 6 ° | In distribution |
| I35-10L-11-0-NS | No Stop | In distribution |
| I35-20L-10 | Angle 6 ° | In distribution |
| I21-229-13L | Height 13 mm | In distribution |
| I35-20S-11-NS | No Stop | In distribution |
| I35-10XL-09-NS | Angle 6 ° | In distribution |
| I35-20M-06-10-NS | Angle 10 ° | In distribution |
| I35-10L-13 | Angle 6 ° | In distribution |
| I35-10L-12-NS | Angle 6 ° | In distribution |
| I15-1030-13P | Depth 30 mm | In distribution |
| I15-1030-15L | Depth 30 mm | In distribution |
| 16-3410-11L | Height 11 mm | In distribution |
| I35-10L-14-NS | Angle 6 ° | In distribution |
| C35-03-04 | In distribution | |
| I35-10M-06-10 | Angle 10 ° | In distribution |
| I35-10XL-05 | Angle 6 ° | In distribution |
| I35-10L-07 | Angle 6 ° | In distribution |
| I35-20M-08-10-NS | Angle 10 ° | In distribution |
| C21-01-06 | In distribution | |
| I35-10L-13-10 | Height 13 mm | In distribution |
| 21-3410-14 | Width 10 mm | In distribution |
| I35-10S-06-NS | Angle 6 ° | In distribution |
| I35-10L-07-10 | Height 7 mm | In distribution |
| I21-2810-10 | Detachable | In distribution |
| 21-3410-10 | Width 10 mm | In distribution |
| I21-269-17 | Detachable | In distribution |
| I35-14-1214C-07 | Depth 12 mm | In distribution |
| 21-3210-16 | Width 10 mm | In distribution |
| I35-20M-07-0-NS | No Stop | In distribution |
Showing 250 of 296 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Latitude-C AM™ Cervical Interbody Fusion System | Degen Medical | 1,529 |
| IdentiTi | Alphatec Spine, Inc. | 1,390 |
| Zavation | Zavation | 1,357 |
| IVA Cage Ti | Diomedical Co., Ltd. | 1,202 |
| Latitude-C Cervical Interbody Spacer System | Degen Medical | 1,185 |
| Peridot Anterior Cervical Intervertebral Body Fusion System | Gbs Commonwealth Co., Ltd. | 1,056 |
| Aleutian® Interbody Systems | VB Spine LLC | 1,017 |
| Valeo Spacer System | Sintx Technologies Inc. | 918 |
| Cascadia™ Interbody System | VB Spine LLC | 823 |
| CoRoent | Nuvasive, Inc. | 815 |
| Tyber Medical | Tyber Medical | 740 |
| Matisse Anterior Cervical Interbody Fusion Cage System | CTL Medical Corporation | 577 |
Showing 12 of 938. All products under Intervertebral Fusion Device With Bone Graft, Cervical
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K171140 | 2017-08-22 |
| K120345 | 2012-06-13 |
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.