Denali® Spinal System
Straight Def. Rod, Dual Hex Stop Size Ø5.5x200 mm,
11manufacturers in China registered for this device type
91catalogue 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 | 2016-11-14 |
| Record revised | 2026-06-25 (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 10.5 mm; length 18 to 600 mm; height 10 mm |
| Distribution end date | 2025-10-06 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 101-07555-SG | Outer Diameter 7.5 mm | In distribution |
| 101-80017-SG | Outer Diameter 5.5 mm | In distribution |
| 101-655350 | Length 350 mm | In distribution |
| 101-65570 | Length 70 mm | In distribution |
| 111-B655300 | Outer Diameter 5.5 mm | In distribution |
| 101-A55120-G1 | Length 120 mm | In distribution |
| 101-80017G | Outer Diameter 5.5 mm | In distribution |
| 101-75525G-SG | Length 25 mm | In distribution |
| 101-55550-SG | Outer Diameter 5.5 mm | In distribution |
| 111-B655250 | Outer Diameter 5.5 mm | In distribution |
| 101-80016-SG | Outer Diameter 5.5 mm | In distribution |
| 111-55585 | Length 85 mm | In distribution |
| 101-085110 | Outer Diameter 8.5 mm | In distribution |
| 101-80011 | Large | In distribution |
| 101-555150-G1 | Outer Diameter 5.5 mm | In distribution |
| 5501-76325 | Length 25 mm | In distribution |
| 101-80019 | Small | In distribution |
| 111-B55500 | Outer Diameter 5.5 mm | In distribution |
| 101-55585-SG | Outer Diameter 5.5 mm | In distribution |
| 101-06550 | Outer Diameter 6.5 mm | In distribution |
| 101-65575-SG | Length 75 mm | In distribution |
| 101-655370 | Length 370 mm | In distribution |
| 101-06545 | Length 45 mm | In distribution |
| 101-555500 | Length 500 mm | In distribution |
| 101-08550 | Length 50 mm | In distribution |
| 101-655470 | Length 470 mm | In distribution |
| 111-B55500-SG | Outer Diameter 5.5 mm | In distribution |
| 101-65580-SG | Outer Diameter 5.5 mm | In distribution |
| 101-55590 | Length 90 mm | In distribution |
| 101-80025 | Outer Diameter 5.5 mm | In distribution |
| 101-07565 | Outer Diameter 7.5 mm | In distribution |
| 111-655310 | Outer Diameter 5.5 mm | In distribution |
| 101-85555D | Outer Diameter 5.5 mm | In distribution |
| 101-B55200 | Length 200 mm | In distribution |
| 111-655350 | Outer Diameter 5.5 mm | In distribution |
| 101-80022-SG | Outer Diameter 5.5 mm | In distribution |
| 101-B655250 | Length 250 mm | In distribution |
| 101-15540 | Outer Diameter 5.5 mm | In distribution |
| 101-14525 | Length 25 mm | In distribution |
| 101-80019-SG | Small | In distribution |
| 101-B55200H | Length 200 mm | In distribution |
| 101-80013-SG | Outer Diameter 5.5 mm | In distribution |
| 101-08560 | Outer Diameter 8.5 mm | In distribution |
| 107-A55600 | Outer Diameter 5.5 mm | In distribution |
| 101-B655500 | Outer Diameter 5.5 mm | In distribution |
| 101-75550-SG | Length 50 mm | In distribution |
| 101-B55150 | Length 150 mm | In distribution |
| 111-B55300 | Length 300 mm | In distribution |
| 101-80013G | Outer Diameter 5.5 mm | In distribution |
| 101-05550 | Length 50 mm | In distribution |
| 111-65580 | Outer Diameter 5.5 mm | In distribution |
| 111-555110 | Outer Diameter 5.5 mm | In distribution |
| 111-B655600 | Length 600 mm | In distribution |
| 106-A55300-G1 | Length 300 mm | In distribution |
| 101-08535 | Outer Diameter 8.5 mm | In distribution |
| 101-16545 | Length 45 mm | In distribution |
| 101-75550G | Length 50 mm | In distribution |
| 106-A55400-G1 | Outer Diameter 5.5 mm | In distribution |
| 101-70018M | Length 18 mm | In distribution |
| 101-85555A | Outer Diameter 5.5 mm | In distribution |
| 101-B655350 | Outer Diameter 5.5 mm | In distribution |
| 101-04545 | Length 45 mm | In distribution |
| 101-65595-SG | Outer Diameter 5.5 mm | In distribution |
| 111-65545 | Length 45 mm | In distribution |
| 101-16520 | Outer Diameter 6.5 mm | In distribution |
| 101-085105 | Length 105 mm | In distribution |
| 101-55595-SG | Length 95 mm | In distribution |
| 101-08540 | Outer Diameter 8.5 mm | In distribution |
| 101-B655325 | Outer Diameter 5.5 mm | In distribution |
| 101-85500D | Outer Diameter 5.5 mm | In distribution |
| 101-175115 | Outer Diameter 7.5 mm | Withdrawn |
| 111-555140 | Outer Diameter 5.5 mm | Withdrawn |
| 101-08585-SG | Length 85 mm | Withdrawn |
| 111-55550 | Length 50 mm | Withdrawn |
| 111-B55200H-G1 | Outer Diameter 5.5 mm | Withdrawn |
| 101-80040 | Outer Diameter 5.5 mm | Withdrawn |
| 101-06595 | Outer Diameter 6.5 mm | Withdrawn |
| 111-555300 | Length 300 mm | Withdrawn |
| 111-555100 | Outer Diameter 5.5 mm | Withdrawn |
| 101-555400-G1 | Length 400 mm | Withdrawn |
| 101-15555 | Outer Diameter 5.5 mm | Withdrawn |
| 101-065105 | Length 105 mm | Withdrawn |
| 111-55580 | Outer Diameter 5.5 mm | Withdrawn |
| 101-S9010 | Height 10 mm | Withdrawn |
| 111-B55300H-G1 | Length 300 mm | Withdrawn |
| 101-11050 | Length 50 mm | Withdrawn |
| 101-B55150-G1 | Length 150 mm | Withdrawn |
| 101-80043 | Outer Diameter 5.5 mm | Withdrawn |
| 101-B55500-G1 | Length 500 mm | Withdrawn |
| 101-11055 | Outer Diameter 10.5 mm | Withdrawn |
| 101-B55200-G1 | Outer Diameter 5.5 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.