Denali® MI Spinal System
Contoured Rod, Bulleted Hex Size Ø5.5x150 mm, Ti
14manufacturers in China registered for this device type
52catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (5), Shanghai (3), Zhejiang (2). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| APS Materials Suzhou | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
Showing 12 of 14. All 14 manufacturers in China registered for Appliance, Fixation, Spinal Intervertebral Body
Record
| Listed by | VB Spine LLC |
|---|---|
| FDA product code | KWQ |
| Device type | Appliance, Fixation, Spinal Intervertebral Body |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| Record published | 2018-11-05 |
| Record revised | 2026-06-24 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Sizes | Length 25 to 280 mm; outer diameter 4.5 to 8.5 mm |
| Distribution end date | 2025-11-12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| M101-17540 | Outer Diameter 7.5 mm | In distribution |
| M101-05550 | Outer Diameter 5.5 mm | In distribution |
| M101-08540 | Outer Diameter 8.5 mm | In distribution |
| 1001-E5545 | Length 45 mm | In distribution |
| 1001-A55280 | Outer Diameter 5.5 mm | In distribution |
| 1001-E5550 | Length 50 mm | In distribution |
| 1001-E5565 | Length 65 mm | In distribution |
| 1001-E55115 | Outer Diameter 5.5 mm | In distribution |
| M101-07545-SG | Length 45 mm | In distribution |
| 1001-E55150-G1 | Outer Diameter 5.5 mm | In distribution |
| 1001-A55270-G1 | Outer Diameter 5.5 mm | In distribution |
| 1001-A55160 | Length 160 mm | In distribution |
| M101-04545 | Outer Diameter 4.5 mm | In distribution |
| 1001-A5560 | Outer Diameter 5.5 mm | In distribution |
| M101-06565 | Length 65 mm | In distribution |
| M101-04540 | Outer Diameter 4.5 mm | In distribution |
| M101-08545 | Length 45 mm | In distribution |
| 1001-A55280-G1 | Outer Diameter 5.5 mm | In distribution |
| M101-04525 | Outer Diameter 4.5 mm | In distribution |
| 1001-E5555-SG | Outer Diameter 5.5 mm | In distribution |
| 1001-E5590 | Outer Diameter 5.5 mm | In distribution |
| M101-08580 | Outer Diameter 8.5 mm | In distribution |
| 1001-E55130 | Length 130 mm | In distribution |
| M101-08535 | Length 35 mm | In distribution |
| 1001-A55240-G1 | Outer Diameter 5.5 mm | In distribution |
| M101-085100 | Length 100 mm | In distribution |
| M101-08560-SG | Length 60 mm | Withdrawn |
| M101-145100 | Length 100 mm | Withdrawn |
| M101-165110 | Outer Diameter 6.5 mm | Withdrawn |
| M101-185110 | Length 110 mm | Withdrawn |
| M101-08590 | Outer Diameter 8.5 mm | Withdrawn |
| M101-06525 | Length 25 mm | Withdrawn |
| M101-07525 | Length 25 mm | Withdrawn |
| M101-07575-SG | Outer Diameter 7.5 mm | Withdrawn |
| M101-17590 | Outer Diameter 7.5 mm | Withdrawn |
| M101-07590-SG | Outer Diameter 7.5 mm | Withdrawn |
| M101-07595-SG | Length 95 mm | Withdrawn |
| M101-06525-SG | Outer Diameter 6.5 mm | Withdrawn |
| M101-18570 | Length 70 mm | Withdrawn |
| M101-08525 | Length 25 mm | Withdrawn |
| M101-15580 | Outer Diameter 5.5 mm | Withdrawn |
| M101-08580-SG | Outer Diameter 8.5 mm | Withdrawn |
| M101-17575 | Outer Diameter 7.5 mm | Withdrawn |
| M101-07540-SG | Length 40 mm | Withdrawn |
| M101-085110-SG | Length 110 mm | Withdrawn |
| M101-08530-SG | Outer Diameter 8.5 mm | Withdrawn |
| M101-14560 | Outer Diameter 4.5 mm | Withdrawn |
| M101-04525-SG | Outer Diameter 4.5 mm | Withdrawn |
| M101-07565-SG | Outer Diameter 7.5 mm | Withdrawn |
| M101-17560 | Length 60 mm | Withdrawn |
| 1001-E55145 | Length 145 mm | Withdrawn |
| M101-18540 | Outer Diameter 8.5 mm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ReLine | Nuvasive, Inc. | 2,998 |
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 2,568 |
| Creo | Globus Medical, Inc. | 1,765 |
| AccelFix Spinal Fixation System | L&K Biomed Co., Ltd. | 1,755 |
| Ozark Cervical Plate System | VB Spine LLC | 1,460 |
| Sirion | Astura Medical | 1,246 |
| Apex Spine System | Spinecraft LLC | 1,187 |
| AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 986 |
| Astra Spine System | Spinecraft LLC | 970 |
| Zavation | Zavation | 966 |
| ACP | Nuvasive, Inc. | 918 |
| Polaris™ 5.5 Spinal System | Biomet Spine | 877 |
Showing 12 of 855. All products under Appliance, Fixation, Spinal Intervertebral Body
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.