Denali® Spinal System
Straight Deformity Rod, Dual Hex Size Ø5.5x200 mm, CoCr
13manufacturers in China registered for this device type
111catalogue 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 | 2026-04-20 (version 13) |
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 16 to 600 mm; height 7.5 mm |
| Distribution end date | 2025-10-03 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 101-65535-SG | Length 35 mm | In distribution |
| 101-65595 | Outer Diameter 5.5 mm | In distribution |
| 101-16575 | Outer Diameter 6.5 mm | In distribution |
| 101-655125 | Outer Diameter 5.5 mm | In distribution |
| 101-A55200 | Length 200 mm | In distribution |
| 101-85555C-SG | Outer Diameter 5.5 mm | In distribution |
| 101-80015G-SG | Outer Diameter 5.5 mm | In distribution |
| 101-70016-SG | Length 16 mm | In distribution |
| 101-16590 | Outer Diameter 6.5 mm | In distribution |
| 101-08595 | Outer Diameter 8.5 mm | In distribution |
| 101-65535 | Length 35 mm | In distribution |
| 101-08570-SG | Outer Diameter 8.5 mm | In distribution |
| 101-55570-SG | Length 70 mm | In distribution |
| 101-555200-G1 | Length 200 mm | In distribution |
| 101-07550-SG | Outer Diameter 7.5 mm | In distribution |
| 101-B55500 | Outer Diameter 5.5 mm | In distribution |
| 101-555400 | Length 400 mm | In distribution |
| 111-55545 | Outer Diameter 5.5 mm | In distribution |
| 101-75550 | Length 50 mm | In distribution |
| 111-655410 | Outer Diameter 5.5 mm | In distribution |
| 5501-86363F | Outer Diameter 5.5 mm | In distribution |
| 101-65550-SG | Length 50 mm | In distribution |
| 101-80026 | Small | In distribution |
| 101-14520 | Length 20 mm | In distribution |
| 111-65570 | Outer Diameter 5.5 mm | In distribution |
| 101-80028-SG | Outer Diameter 5.5 mm | In distribution |
| 101-65560-SG | Outer Diameter 5.5 mm | In distribution |
| 101-555200 | Outer Diameter 5.5 mm | In distribution |
| 101-08575 | Outer Diameter 8.5 mm | In distribution |
| 101-70021M | Length 21 mm | In distribution |
| 5501-76350 | Length 50 mm | In distribution |
| 101-07545 | Length 45 mm | In distribution |
| 101-18590 | Length 90 mm | In distribution |
| 101-07550 | Length 50 mm | In distribution |
| 101-73040-SG | Small | In distribution |
| 101-80013G-SG | Outer Diameter 5.5 mm | In distribution |
| 101-655100 | Length 100 mm | In distribution |
| 101-08565 | Length 65 mm | In distribution |
| 101-70020M | Length 20 mm | In distribution |
| 101-555150-SG | Outer Diameter 5.5 mm | In distribution |
| 101-74050 | Outer Diameter 5.5 mm | In distribution |
| 101-16535 | Outer Diameter 6.5 mm | In distribution |
| 111-B655350 | Outer Diameter 5.5 mm | In distribution |
| 111-655370 | Length 370 mm | In distribution |
| 101-17565 | Length 65 mm | In distribution |
| 101-655450 | Length 450 mm | In distribution |
| 111-B55200 | Outer Diameter 5.5 mm | In distribution |
| 111-N55300 | Length 300 mm | In distribution |
| 101-085100 | Length 100 mm | In distribution |
| 101-08575-SG | Length 75 mm | In distribution |
| 111-B655375 | Length 375 mm | In distribution |
| 101-65585-SG | Outer Diameter 5.5 mm | In distribution |
| 101-65530-SG | Length 30 mm | In distribution |
| 101-05545 | Outer Diameter 5.5 mm | In distribution |
| 101-04525 | Length 25 mm | In distribution |
| 101-75525G | Length 25 mm | In distribution |
| 101-85500D-SG | Outer Diameter 5.5 mm | In distribution |
| 101-80018-SG | Outer Diameter 5.5 mm | In distribution |
| 101-70018-SG | Length 18 mm | In distribution |
| 111-655470 | Outer Diameter 5.5 mm | In distribution |
| 101-80029 | Small | In distribution |
| 111-555130 | Length 130 mm | In distribution |
| 111-655150 | Outer Diameter 5.5 mm | In distribution |
| 101-55590-SG | Length 90 mm | In distribution |
| 101-76070-SG | Extra Large | In distribution |
| 101-80020-SG | Large | In distribution |
| 101-55555-SG | Outer Diameter 5.5 mm | In distribution |
| 101-A55300 | Length 300 mm | In distribution |
| 101-80022 | Outer Diameter 5.5 mm | In distribution |
| 106-A55200-G1 | Length 200 mm | In distribution |
| 101-70022-SG | Length 22 mm | In distribution |
| 111-655125 | Length 125 mm | In distribution |
| 101-15520 | Outer Diameter 5.5 mm | In distribution |
| 101-06530 | Outer Diameter 6.5 mm | In distribution |
| 101-80014 | Small | In distribution |
| 111-65555 | Outer Diameter 5.5 mm | In distribution |
| 111-65535 | Outer Diameter 5.5 mm | In distribution |
| 101-655125-G1 | Outer Diameter 5.5 mm | In distribution |
| 101-55540 | Outer Diameter 5.5 mm | In distribution |
| 101-18560 | Outer Diameter 8.5 mm | In distribution |
| 101-14535 | Outer Diameter 4.5 mm | In distribution |
| 111-55555 | Length 55 mm | In distribution |
| 101-65545-SG | Length 45 mm | In distribution |
| 101-555140 | Outer Diameter 5.5 mm | In distribution |
| 101-07575 | Length 75 mm | In distribution |
| 101-05530 | Outer Diameter 5.5 mm | In distribution |
| 101-85555E-SG | Outer Diameter 5.5 mm | In distribution |
| 101-755100G-SG | Length 100 mm | In distribution |
| 101-80012 | Medium | In distribution |
| 101-S9007 | Height 7.5 mm | Withdrawn |
| 111-55570 | Outer Diameter 5.5 mm | Withdrawn |
| 111-B55600-G1 | Outer Diameter 5.5 mm | Withdrawn |
| 111-555400 | Length 400 mm | Withdrawn |
| 111-55590 | Outer Diameter 5.5 mm | Withdrawn |
| 101-555130-G1 | Length 130 mm | Withdrawn |
| 101-B55500H-G1 | Outer Diameter 5.5 mm | Withdrawn |
| 101-07540-SG | Outer Diameter 7.5 mm | Withdrawn |
| 101-07545-SG | Length 45 mm | Withdrawn |
| 111-B655325 | Outer Diameter 5.5 mm | Withdrawn |
| 111-B55500H | Length 500 mm | Withdrawn |
| 101-15560 | Outer Diameter 5.5 mm | Withdrawn |
| 101-B55300-G1 | Outer Diameter 5.5 mm | Withdrawn |
| 101-B55400H-G1 | Length 400 mm | Withdrawn |
| 111-A55300-G1 | Length 300 mm | Withdrawn |
| 101-06590 | Outer Diameter 6.5 mm | Withdrawn |
| 101-B55200H-G1 | Outer Diameter 5.5 mm | Withdrawn |
| 101-A55400 | Outer Diameter 5.5 mm | Withdrawn |
| 111-B55500H-G1 | Length 500 mm | Withdrawn |
| 101-07575-SG | Length 75 mm | Withdrawn |
| 101-15565 | Outer Diameter 5.5 mm | Withdrawn |
| 101-06560-SG | Outer Diameter 6.5 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.