Denali® Spinal System
Transverse Connector, Fixed Size 26 mm, NATURAL BR
7manufacturers in China registered for this device type
77catalogue 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 | 2015-09-24 |
| Record revised | 2026-06-25 (version 13) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| 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 10.5 mm; length 18 to 600 mm |
| Distribution end date | 2025-10-06 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5501-86363FN | Outer Diameter 5.5 mm | In distribution |
| 101-70026 | Length 26 mm | In distribution |
| 101-555500-G1 | Length 500 mm | In distribution |
| 101-80017G-SG | Outer Diameter 5.5 mm | In distribution |
| 101-55575-SG | Outer Diameter 5.5 mm | In distribution |
| 101-655330 | Length 330 mm | In distribution |
| 101-55545-SG | Outer Diameter 5.5 mm | In distribution |
| 101-B655600 | Length 600 mm | In distribution |
| 107-A55500-G1 | Outer Diameter 5.5 mm | In distribution |
| 5501-86363E | Outer Diameter 5.5 mm | In distribution |
| 101-16560 | Outer Diameter 6.5 mm | In distribution |
| 111-65565 | Outer Diameter 5.5 mm | In distribution |
| 107-A55500-SG | Length 500 mm | In distribution |
| 101-70032 | Length 32 mm | In distribution |
| 101-15550 | Outer Diameter 5.5 mm | In distribution |
| 101-74050-SG | Medium | In distribution |
| 101-18570 | Length 70 mm | In distribution |
| 101-755100G | Length 100 mm | In distribution |
| 101-N55300 | Outer Diameter 5.5 mm | In distribution |
| 101-655410 | Length 410 mm | In distribution |
| 111-B655500 | Outer Diameter 5.5 mm | In distribution |
| 101-80014-SG | Outer Diameter 5.5 mm | In distribution |
| 101-18585 | Length 85 mm | In distribution |
| 106-A55600 | Outer Diameter 5.5 mm | In distribution |
| 101-A55500-SG | Length 500 mm | In distribution |
| 101-80010 | Medium | In distribution |
| 101-75060-SG | Large | In distribution |
| 101-65560 | Length 60 mm | In distribution |
| 101-65580 | Length 80 mm | In distribution |
| 101-16570 | Length 70 mm | In distribution |
| 101-70035 | Length 35 mm | In distribution |
| 101-08530 | Outer Diameter 8.5 mm | In distribution |
| 101-55565 | Length 65 mm | In distribution |
| 101-655125-SG | Length 125 mm | In distribution |
| 107-A55300-G1 | Length 300 mm | In distribution |
| 101-555110-SG | Outer Diameter 5.5 mm | In distribution |
| 101-80021-SG | Outer Diameter 5.5 mm | In distribution |
| 101-80023-SG | Outer Diameter 5.5 mm | In distribution |
| 101-55580 | Length 80 mm | In distribution |
| 101-755100 | Length 100 mm | In distribution |
| 101-65540-SG | Length 40 mm | In distribution |
| 101-175105 | Outer Diameter 7.5 mm | In distribution |
| 101-05560 | Length 60 mm | In distribution |
| 101-70018 | Length 18 mm | In distribution |
| 101-17520 | Outer Diameter 7.5 mm | In distribution |
| 101-65565-SG | Outer Diameter 5.5 mm | In distribution |
| 107-A55400-G1 | Outer Diameter 5.5 mm | In distribution |
| 101-18575 | Length 75 mm | In distribution |
| 101-06545-SG | Length 45 mm | In distribution |
| 101-655490 | Outer Diameter 5.5 mm | In distribution |
| 101-14540 | Length 40 mm | In distribution |
| 101-A55500 | Length 500 mm | In distribution |
| 101-80012G-SG | Outer Diameter 5.5 mm | In distribution |
| 101-075100 | Length 100 mm | In distribution |
| 101-17530 | Length 30 mm | In distribution |
| 101-18595 | Length 95 mm | In distribution |
| 101-08545 | Outer Diameter 8.5 mm | In distribution |
| 111-655490 | Length 490 mm | In distribution |
| 101-165110 | Length 110 mm | In distribution |
| 111-65550 | Length 50 mm | In distribution |
| 111-65575 | Length 75 mm | In distribution |
| 101-80039 | Medium | In distribution |
| 101-19550 | Outer Diameter 9.5 mm | Withdrawn |
| 101-B55300H-G1 | Outer Diameter 5.5 mm | Withdrawn |
| 101-80044 | Outer Diameter 5.5 mm | Withdrawn |
| 111-A55200-G1 | Length 200 mm | Withdrawn |
| 111-A55500-G1 | Length 500 mm | Withdrawn |
| 101-B55400-G1 | Length 400 mm | Withdrawn |
| 101-11045 | Length 45 mm | Withdrawn |
| 101-06585-SG | Length 85 mm | Withdrawn |
| 106-A55600-G1 | Length 600 mm | Withdrawn |
| 111-655150-G1 | Length 150 mm | Withdrawn |
| 101-80047 | Outer Diameter 5.5 mm | Withdrawn |
| 101-80046 | Large | Withdrawn |
| 101-06580-SG | Length 80 mm | Withdrawn |
| 101-185115 | Outer Diameter 8.5 mm | Withdrawn |
| 111-B55200-G1 | Outer Diameter 5.5 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.