Denali® MI Spinal System
Contoured Rod, Bulleted Hex Size Ø5.5x130 mm, Ti
13manufacturers in China registered for this device type
53catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (7), Shanghai (2), Shandong (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| 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 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Changzhou Yonghua Medical Instruments Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 8 |
| Jiangsu Ideal Medical Science & Technology Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 7 |
Showing 12 of 13. All 13 manufacturers in China registered for Orthosis, Spinal Pedicle Fixation
Record
| Listed by | VB Spine LLC |
|---|---|
| FDA product code | MNI |
| Device type | Orthosis, Spinal Pedicle Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Record published | 2016-11-14 |
| Record revised | 2026-06-24 (version 10) |
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 30 to 500 mm; outer diameter 4.5 to 8.5 mm |
| Distribution end date | 2025-11-12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| M101-07550-SG | Length 50 mm | In distribution |
| M101-05540-SG | Length 40 mm | In distribution |
| 1001-A55500 | Length 500 mm | In distribution |
| M101-06555 | Length 55 mm | In distribution |
| M101-04530 | Length 30 mm | In distribution |
| 1001-A5590 | Length 90 mm | In distribution |
| 1001-A55240 | Outer Diameter 5.5 mm | In distribution |
| 1001-A55170-G1 | Outer Diameter 5.5 mm | In distribution |
| M101-04535 | Outer Diameter 4.5 mm | In distribution |
| M101-15550 | Length 50 mm | In distribution |
| 1001-A55225-G1 | Outer Diameter 5.5 mm | In distribution |
| 1001-A55120 | Outer Diameter 5.5 mm | In distribution |
| 1001-A5570 | Length 70 mm | In distribution |
| M101-05545-SG | Outer Diameter 5.5 mm | In distribution |
| 1001-E5550-SG | Length 50 mm | In distribution |
| M101-07530 | Outer Diameter 7.5 mm | In distribution |
| 1001-A55180-G1 | Length 180 mm | In distribution |
| 1001-A55175-G1 | Length 175 mm | In distribution |
| 1001-E5585-SG | Outer Diameter 5.5 mm | In distribution |
| M101-06535 | Length 35 mm | In distribution |
| M101-14530 | Outer Diameter 4.5 mm | In distribution |
| 1001-E5535-SG | Outer Diameter 5.5 mm | In distribution |
| 1001-A55140 | Length 140 mm | In distribution |
| 1001-A55300-G1 | Length 300 mm | In distribution |
| M101-05545 | Outer Diameter 5.5 mm | In distribution |
| M101-07550 | Length 50 mm | In distribution |
| M101-07585 | Outer Diameter 7.5 mm | In distribution |
| 1001-A55500-G1 | Outer Diameter 5.5 mm | In distribution |
| M101-14545 | Length 45 mm | In distribution |
| 1001-A55210 | Outer Diameter 5.5 mm | In distribution |
| 1001-E55130-G1 | Outer Diameter 5.5 mm | In distribution |
| M101-04550 | Outer Diameter 4.5 mm | In distribution |
| M101-15570 | Length 70 mm | Withdrawn |
| M101-06530-SG | Outer Diameter 6.5 mm | Withdrawn |
| M101-17585 | Length 85 mm | Withdrawn |
| M101-175110 | Length 110 mm | Withdrawn |
| M101-075110-SG | Length 110 mm | Withdrawn |
| M101-085110 | Length 110 mm | Withdrawn |
| M101-17595 | Outer Diameter 7.5 mm | Withdrawn |
| M101-145105 | Outer Diameter 4.5 mm | Withdrawn |
| M101-14555 | Length 55 mm | Withdrawn |
| M101-07560-SG | Outer Diameter 7.5 mm | Withdrawn |
| M101-165100 | Outer Diameter 6.5 mm | Withdrawn |
| M101-18550 | Length 50 mm | Withdrawn |
| M101-08565 | Length 65 mm | Withdrawn |
| M101-16590 | Length 90 mm | Withdrawn |
| M101-08550-SG | Length 50 mm | Withdrawn |
| M101-14565 | Outer Diameter 4.5 mm | Withdrawn |
| M101-185105 | Length 105 mm | Withdrawn |
| M101-085105 | Length 105 mm | Withdrawn |
| M101-185100 | Length 100 mm | Withdrawn |
| M101-18565 | Outer Diameter 8.5 mm | Withdrawn |
| M101-14585 | Length 85 mm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 2,342 |
| Creo | Globus Medical, Inc. | 1,784 |
| ReLine | Nuvasive, Inc. | 1,718 |
| AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 1,525 |
| Apex Spine System | Spinecraft LLC | 1,114 |
| Revere | Globus Medical, Inc. | 1,051 |
| LnK Spinal Fixation System | L&K Biomed Co., Ltd. | 974 |
| LnK Basic Spinal Fixation System | L&K Biomed Co., Ltd. | 935 |
| Arsenal | Alphatec Spine, Inc. | 932 |
| Zavation | Zavation | 864 |
| Polaris™ 5.5 Spinal System | Biomet Spine | 809 |
| Apex-DL Spine System | Spinecraft LLC | 792 |
Showing 12 of 950. All products under Orthosis, Spinal Pedicle Fixation
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.