Denali® MI Spinal System
Contoured Rod, Bulleted Hex Size Ø5.5x115 mm, Ti
15manufacturers in China registered for this device type
53catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (6), Shanghai (3), Shandong (3). 6 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 |
| 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 |
| Shanghai Reach Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 30 |
| Changzhou Geasure Medical Apparatus AND Instruments Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 25 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
Showing 12 of 15. All 15 manufacturers in China registered for Thoracolumbosacral Pedicle Screw System
Record
| Listed by | VB Spine LLC |
|---|---|
| FDA product code | NKB |
| Device type | Thoracolumbosacral Pedicle Screw System |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Record published | 2015-09-24 |
| 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 | Outer diameter 4.5 to 8.5 mm; length 25 to 290 mm |
| Distribution end date | 2025-11-12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| M101-05540 | Outer Diameter 5.5 mm | In distribution |
| M101-06530 | Length 30 mm | In distribution |
| M101-16545 | Outer Diameter 6.5 mm | In distribution |
| 1001-E5565-SG | Length 65 mm | In distribution |
| 1001-E5570-SG | Length 70 mm | In distribution |
| 1001-E5535 | Outer Diameter 5.5 mm | In distribution |
| 1001-E5530 | Outer Diameter 5.5 mm | In distribution |
| M101-05535-SG | Length 35 mm | In distribution |
| 1001-A55140-G1 | Length 140 mm | In distribution |
| 1001-E55100 | Length 100 mm | In distribution |
| M101-17535 | Length 35 mm | In distribution |
| M101-14540 | Outer Diameter 4.5 mm | In distribution |
| M101-075100 | Length 100 mm | In distribution |
| 1001-E5595 | Outer Diameter 5.5 mm | In distribution |
| M101-05535 | Length 35 mm | In distribution |
| 1001-E5540-SG | Outer Diameter 5.5 mm | In distribution |
| 1001-A55180 | Outer Diameter 5.5 mm | In distribution |
| M101-16540 | Outer Diameter 6.5 mm | In distribution |
| 1001-E5595-SG | Length 95 mm | In distribution |
| M101-07535 | Outer Diameter 7.5 mm | In distribution |
| M101-06555-SG | Length 55 mm | In distribution |
| M101-15540 | Length 40 mm | In distribution |
| 1001-A55160-G1 | Length 160 mm | In distribution |
| 1001-E55110 | Length 110 mm | In distribution |
| 1001-E55115-G1 | Length 115 mm | In distribution |
| M101-15535 | Outer Diameter 5.5 mm | In distribution |
| 1001-A55130-G1 | Outer Diameter 5.5 mm | In distribution |
| M101-08550 | Outer Diameter 8.5 mm | In distribution |
| 1001-A55290 | Length 290 mm | In distribution |
| M101-06545 | Length 45 mm | In distribution |
| M101-18585 | Length 85 mm | Withdrawn |
| M101-18560 | Length 60 mm | Withdrawn |
| M101-15525 | Length 25 mm | Withdrawn |
| M101-085100-SG | Outer Diameter 8.5 mm | Withdrawn |
| M101-14595 | Outer Diameter 4.5 mm | Withdrawn |
| M101-075110 | Outer Diameter 7.5 mm | Withdrawn |
| M101-07595 | Length 95 mm | Withdrawn |
| M101-08525-SG | Length 25 mm | Withdrawn |
| M101-04535-SG | Length 35 mm | Withdrawn |
| M101-18535 | Length 35 mm | Withdrawn |
| M101-08565-SG | Outer Diameter 8.5 mm | Withdrawn |
| M101-15590 | Outer Diameter 5.5 mm | Withdrawn |
| M101-07570-SG | Length 70 mm | Withdrawn |
| M101-085105-SG | Outer Diameter 8.5 mm | Withdrawn |
| M101-15595 | Length 95 mm | Withdrawn |
| M101-05555-SG | Outer Diameter 5.5 mm | Withdrawn |
| M101-05565 | Outer Diameter 5.5 mm | Withdrawn |
| M101-08595-SG | Length 95 mm | Withdrawn |
| M101-08535-SG | Length 35 mm | Withdrawn |
| M101-17525 | Outer Diameter 7.5 mm | Withdrawn |
| M101-18530 | Length 30 mm | Withdrawn |
| M101-165105 | Length 105 mm | Withdrawn |
| M101-16525 | Outer Diameter 6.5 mm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| The Jasper Spinal Fixation System | Gbs Commonwealth Co., Ltd. | 32,491 |
| Invictus | Alphatec Spine, Inc. | 4,722 |
| Vital Spinal Fixation System | Highridge Medical, LLC | 4,422 |
| Innoverse Spinal System | CG MedTech Co., Ltd. | 4,240 |
| 4CIS® Chiron Spinal Fixation System | Alpha AI Co., Ltd. | 3,787 |
| LnK Spinal Fixation System | L&K Biomed Co., Ltd. | 3,522 |
| Hedjet System | Medyssey Co., Ltd. | 3,438 |
| Anax™ 5.5 Spinal System | CG MedTech Co., Ltd. | 3,424 |
| Mega Plus MIS Spine System | BK Meditech Co., Ltd. | 3,396 |
| ReLine | Nuvasive, Inc. | 2,882 |
| Nex-D2 | Next Orthosurgical | 2,765 |
| AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 2,386 |
Showing 12 of 1,490. All products under Thoracolumbosacral Pedicle Screw System
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.