Denali® MI Spinal System
Contoured Rod, Bulleted Hex Size Ø5.5x140 mm, Ti
11manufacturers in China registered for this device type
52catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (5), Shandong (2), Shanghai (1). 5 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 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| 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 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
Record
| Listed by | VB Spine LLC |
|---|---|
| FDA product code | KWP |
| Device type | Appliance, Fixation, Spinal Interlaminal |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3050 |
| Record published | 2018-11-05 |
| Record revised | 2026-06-24 (version 11) |
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 | Outer diameter 4.5 to 8.5 mm; length 25 to 260 mm |
| Distribution end date | 2025-11-12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1001-A55220 | Outer Diameter 5.5 mm | In distribution |
| 1001-E55140-G1 | Outer Diameter 5.5 mm | In distribution |
| 1001-A55230 | Length 230 mm | In distribution |
| 1001-E55150 | Length 150 mm | In distribution |
| 1001-E55105 | Outer Diameter 5.5 mm | In distribution |
| 1001-E5555 | Length 55 mm | In distribution |
| 1001-E55140 | Outer Diameter 5.5 mm | In distribution |
| 1001-A55170 | Outer Diameter 5.5 mm | In distribution |
| 1001-E5580 | Length 80 mm | In distribution |
| 1001-A55260-G1 | Outer Diameter 5.5 mm | In distribution |
| M101-06540-SG | Length 40 mm | In distribution |
| M101-07565 | Length 65 mm | In distribution |
| 1001-A55250-G1 | Outer Diameter 5.5 mm | In distribution |
| M101-16555 | Outer Diameter 6.5 mm | In distribution |
| 1001-E55150-SG | Outer Diameter 5.5 mm | In distribution |
| 1001-A55100 | Length 100 mm | In distribution |
| 1001-A5580 | Length 80 mm | In distribution |
| 1001-A55130 | Length 130 mm | In distribution |
| 1001-E5560 | Outer Diameter 5.5 mm | In distribution |
| 1001-E55135 | Outer Diameter 5.5 mm | In distribution |
| 1001-A5540 | Length 40 mm | In distribution |
| 1001-A55210-G1 | Outer Diameter 5.5 mm | In distribution |
| 1001-E55120-G1 | Outer Diameter 5.5 mm | In distribution |
| M101-05555 | Length 55 mm | In distribution |
| 1001-A55200 | Outer Diameter 5.5 mm | In distribution |
| M101-07560 | Outer Diameter 7.5 mm | In distribution |
| M101-16535 | Outer Diameter 6.5 mm | In distribution |
| M101-17530 | Outer Diameter 7.5 mm | Withdrawn |
| M101-175105 | Length 105 mm | Withdrawn |
| M101-15555 | Outer Diameter 5.5 mm | Withdrawn |
| M101-18555 | Length 55 mm | Withdrawn |
| M101-145110 | Length 110 mm | Withdrawn |
| M101-07530-SG | Outer Diameter 7.5 mm | Withdrawn |
| M101-08585-SG | Outer Diameter 8.5 mm | Withdrawn |
| M101-16560 | Length 60 mm | Withdrawn |
| M101-175100 | Length 100 mm | Withdrawn |
| M101-08555-SG | Outer Diameter 8.5 mm | Withdrawn |
| M101-14575 | Length 75 mm | Withdrawn |
| M101-07525-SG | Outer Diameter 7.5 mm | Withdrawn |
| M101-18575 | Outer Diameter 8.5 mm | Withdrawn |
| M101-18525 | Outer Diameter 8.5 mm | Withdrawn |
| M101-17580 | Outer Diameter 7.5 mm | Withdrawn |
| M101-16595 | Length 95 mm | Withdrawn |
| M101-07585-SG | Length 85 mm | Withdrawn |
| M101-16570 | Outer Diameter 6.5 mm | Withdrawn |
| M101-075105-SG | Outer Diameter 7.5 mm | Withdrawn |
| M101-06560-SG | Outer Diameter 6.5 mm | Withdrawn |
| M101-08575-SG | Length 75 mm | Withdrawn |
| M101-08595 | Outer Diameter 8.5 mm | Withdrawn |
| M101-17565 | Length 65 mm | Withdrawn |
| M101-15560 | Length 60 mm | Withdrawn |
| M101-14570 | Length 70 mm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Invictus | Alphatec Spine, Inc. | 5,422 |
| ReLine | Nuvasive, Inc. | 4,439 |
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 3,188 |
| Creo | Globus Medical, Inc. | 1,992 |
| Apex Spine System | Spinecraft LLC | 1,319 |
| LnK Spinal Fixation System | L&K Biomed Co., Ltd. | 1,271 |
| Perla ® TL | Spineart SA | 1,035 |
| Astra Spine System | Spinecraft LLC | 1,003 |
| LineSider | Highridge Medical, LLC | 948 |
| Apex-DL Spine System | Spinecraft LLC | 909 |
| Revere | Globus Medical, Inc. | 875 |
| AccelFix Spinal Fixation System | L&K Biomed Co., Ltd. | 841 |
Showing 12 of 536. All products under Appliance, Fixation, Spinal Interlaminal
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.