Denali® MI Spinal System
Contoured Rod, Bulleted Hex Size Ø5.5x100 mm, Ti
7manufacturers in China registered for this device type
38catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (4), Shandong (2), Shanghai (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| 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 |
Record
| Listed by | VB Spine LLC |
|---|---|
| FDA product code | OSH |
| Device type | Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Record published | 2019-01-08 |
| 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 25 to 275 mm; outer diameter 4.5 to 8.5 mm |
| Distribution end date | 2025-03-27 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1001-A55275-G1 | Length 275 mm | In distribution |
| 1001-A5550 | Length 50 mm | In distribution |
| 1001-E5575-SG | Outer Diameter 5.5 mm | In distribution |
| 1001-E55100-SG | Outer Diameter 5.5 mm | In distribution |
| M101-08575 | Length 75 mm | In distribution |
| 1001-A55275 | Length 275 mm | In distribution |
| 1001-E55125 | Outer Diameter 5.5 mm | In distribution |
| M101-17550 | Outer Diameter 7.5 mm | In distribution |
| M101-15545 | Outer Diameter 5.5 mm | In distribution |
| 1001-A55250 | Length 250 mm | In distribution |
| 1001-E5540 | Outer Diameter 5.5 mm | In distribution |
| M101-07570 | Outer Diameter 7.5 mm | In distribution |
| M101-08585 | Length 85 mm | In distribution |
| 1001-A55150 | Length 150 mm | In distribution |
| 1001-E5590-SG | Outer Diameter 5.5 mm | In distribution |
| M101-05530 | Outer Diameter 5.5 mm | In distribution |
| 1001-E5570 | Outer Diameter 5.5 mm | In distribution |
| 1001-A55175 | Outer Diameter 5.5 mm | In distribution |
| 1001-A55150-G1 | Outer Diameter 5.5 mm | In distribution |
| M101-07545 | Length 45 mm | In distribution |
| M101-14535 | Outer Diameter 4.5 mm | In distribution |
| M101-16550 | Outer Diameter 6.5 mm | In distribution |
| M101-07575 | Length 75 mm | In distribution |
| 1001-A55220-G1 | Outer Diameter 5.5 mm | In distribution |
| M101-14550 | Length 50 mm | In distribution |
| M101-07540 | Length 40 mm | In distribution |
| M101-16530 | Outer Diameter 6.5 mm | In distribution |
| M101-07580-SG | Outer Diameter 7.5 mm | Withdrawn |
| M101-05525-SG | Length 25 mm | Withdrawn |
| M101-16585 | Length 85 mm | Withdrawn |
| M101-18545 | Outer Diameter 8.5 mm | Withdrawn |
| M101-16580 | Length 80 mm | Withdrawn |
| M101-08590-SG | Length 90 mm | Withdrawn |
| M101-18595 | Length 95 mm | Withdrawn |
| M101-15565 | Length 65 mm | Withdrawn |
| M101-15585 | Outer Diameter 5.5 mm | Withdrawn |
| M101-07590 | Outer Diameter 7.5 mm | Withdrawn |
| M101-18590 | Outer Diameter 8.5 mm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Creo | Globus Medical, Inc. | 1,821 |
| ReLine | Nuvasive, Inc. | 1,093 |
| Olympic | Astura Medical | 951 |
| Nex-D2 | Next Orthosurgical | 887 |
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 876 |
| Arsenal | Alphatec Spine, Inc. | 820 |
| Apex-DL Spine System | Spinecraft LLC | 691 |
| Polaris™ 4.75 Spinal System | Biomet Spine | 413 |
| Expedium | Medos International Sàrl | 400 |
| Implanet Spine System | Implanet | 386 |
| Everest® Spinal System | VB Spine LLC | 299 |
| Arsenal Deformity Spinal Fixation System | Alphatec Spine, Inc. | 258 |
Showing 12 of 73. All products under Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis
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.