Dark Star Deformity
Polyaxial, Spring Loading Screwdriver - Long Configuration
13manufacturers in China registered for this device type
202catalogue numbers in this listing
1510(k) clearance
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, Spondylolisthesis Spinal Fixation
Record
| Listed by | Republic Spine, United States |
|---|---|
| FDA product code | MNH |
| Device type | Orthosis, Spondylolisthesis Spinal Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Complaint-file establishment, Manufacturer |
| Record published | 2024-06-26 |
| Record revised | 2025-03-21 (version 8) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Sizes | Length 25 to 450 mm; outer diameter 5.5 to 9 mm |
| Distribution end date | 2016-05-30 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 100135-075 | Outer Diameter 5.5 mm | In distribution |
| 100220-S-5545 | Outer Diameter 5.5 mm | In distribution |
| 100135-160 | Outer Diameter 5.5 mm | In distribution |
| 100208-7535 | 7.5mm diameter | In distribution |
| 100220-S-8540 | Outer Diameter 8.5 mm | In distribution |
| 100220-S-7590 | Outer Diameter 7.5 mm | In distribution |
| 100235-8545 | 8.5mm diameter | In distribution |
| 100135-150 | Outer Diameter 5.5 mm | In distribution |
| 100220-C-6530 | Length 30 mm | In distribution |
| 100020-050 | Outer Diameter 5.5 mm | In distribution |
| 100235-7545 | 7.5mm diameter | In distribution |
| 100008-8545 | 8.5mm diameter | In distribution |
| 100235-6550 | 6.5mm diameter | In distribution |
| 100235-5535 | 5.5mm diameter | In distribution |
| 100220-S-6550 | Outer Diameter 6.5 mm | In distribution |
| 100235-8590 | 8.5mm diameter | In distribution |
| 100220-S-7580 | Outer Diameter 7.5 mm | In distribution |
| 100220-C-9040 | Outer Diameter 9.0 mm | In distribution |
| 100208-7560 | 7.5mm diameter | In distribution |
| 100220-C-8580 | Outer Diameter 8.5 mm | In distribution |
| 100055 | Outer Diameter 5.5 mm | In distribution |
| 100208-6560 | 6.5mm diameter | In distribution |
| 100008-8535 | 8.5mm diameter | In distribution |
| 100220-S-7545 | Outer Diameter 7.5 mm | In distribution |
| 100208-5535 | 5.5mm diameter | In distribution |
| 100135-190 | Outer Diameter 5.5 mm | In distribution |
| 100136-040 | Outer Diameter 5.5 mm | In distribution |
| 100135-180 | Outer Diameter 5.5 mm | In distribution |
| 100208-6530 | 6.5mm diameter | In distribution |
| 100272 | In distribution | |
| 100135-055 | Outer Diameter 5.5 mm | In distribution |
| 100220-S-9035 | Outer Diameter 9.0 mm | In distribution |
| 100220-C-75100 | Outer Diameter 7.5 mm | In distribution |
| 100136-280 | Outer Diameter 5.5 mm | In distribution |
| 100136-035 | Outer Diameter 5.5 mm | In distribution |
| 100136-300 | Outer Diameter 5.5 mm | In distribution |
| 100220-S-7535 | Outer Diameter 7.5 mm | In distribution |
| 100118 | Outer Diameter 5.5 mm | In distribution |
| 100054-01 | In distribution | |
| 100057 | Outer Diameter 7.5 mm | In distribution |
| 100135-035 | Outer Diameter 5.5 mm | In distribution |
| 100208-5545 | 5.5mm diameter | In distribution |
| 100220-S-6530 | Outer Diameter 6.5 mm | In distribution |
| 100220-C-85100 | Outer Diameter 8.5 mm | In distribution |
| 100220-C-65100 | Length 100 mm | In distribution |
| 100220-S-6560 | Length 60 mm | In distribution |
| 100080-120 | Outer Diameter 5.5 mm | In distribution |
| 100208-7570 | 7.5mm diameter | In distribution |
| 100220-S-7560 | Outer Diameter 7.5 mm | In distribution |
| 100220-C-85110 | Outer Diameter 8.5 mm | In distribution |
| 100220-C-7535 | Length 35 mm | In distribution |
| 100080-060 | Outer Diameter 5.5 mm | In distribution |
| 100208-7580 | 7.5mm diameter | In distribution |
| 100135-130 | Outer Diameter 5.5 mm | In distribution |
| 100220-S-7570 | Outer Diameter 7.5 mm | In distribution |
| 100135-080 | Outer Diameter 5.5 mm | In distribution |
| 100220-C-7590 | Outer Diameter 7.5 mm | In distribution |
| 100208-8535 | 8.5mm diameter | In distribution |
| 100235-7535 | 7.5mm diameter | In distribution |
| 100220-S-75100 | Outer Diameter 7.5 mm | In distribution |
| 100135-070 | Outer Diameter 5.5 mm | In distribution |
| 100136-065 | Outer Diameter 5.5 mm | In distribution |
| 100278 | In distribution | |
| 100220-S-8580 | Outer Diameter 8.5 mm | In distribution |
| 100220-S-8570 | Outer Diameter 8.5 mm | In distribution |
| 100220-C-6580 | Length 80 mm | In distribution |
| 100080-080 | Outer Diameter 5.5 mm | In distribution |
| 100220-S-65100 | Length 100 mm | In distribution |
| 100235-75100 | 7.5mm diameter | In distribution |
| 100208-7545 | 7.5mm diameter | In distribution |
| 100220-C-8555 | Length 55 mm | In distribution |
| 100220-C-8590 | Outer Diameter 8.5 mm | In distribution |
| 100136-200 | Outer Diameter 5.5 mm | In distribution |
| 100080-035 | Outer Diameter 5.5 mm | In distribution |
| 100235-7570 | 7.5mm diameter | In distribution |
| 100081 | In distribution | |
| 100220-S-8590 | Outer Diameter 8.5 mm | In distribution |
| 100136-080 | Outer Diameter 5.5 mm | In distribution |
| 100208-8555 | 8.5mm diameter | In distribution |
| 100220-C-6570 | Length 70 mm | In distribution |
| 100208-75100 | 7.5mm diameter | In distribution |
| 100264 | In distribution | |
| 100235-7560 | 7.5mm diameter | In distribution |
| 100136-240 | Outer Diameter 5.5 mm | In distribution |
| 100080-065 | Outer Diameter 5.5 mm | In distribution |
| 100220-C-7545 | Length 45 mm | In distribution |
| 100208-75110 | 7.5mm diameter | In distribution |
| 100235-6545 | 6.5mm diameter | In distribution |
| 100080-025 | Outer Diameter 5.5 mm | In distribution |
| 100260-02 | In distribution | |
| 100220-C-5545 | Length 45 mm | In distribution |
| 100008-8560 | 8.5mm diameter | In distribution |
| 100135-025 | Outer Diameter 5.5 mm | In distribution |
| 100220-S-6590 | Length 90 mm | In distribution |
| 100220-C-9030 | Outer Diameter 9.0 mm | In distribution |
| 100135-120 | Outer Diameter 5.5 mm | In distribution |
| 100259 | In distribution | |
| 100235-5560 | 5.5mm diameter | In distribution |
| 100020-035 | Outer Diameter 5.5 mm | In distribution |
| 100220-C-7580 | Outer Diameter 7.5 mm | In distribution |
| 100135-030 | Outer Diameter 5.5 mm | In distribution |
| 100120 | Outer Diameter 7.5 mm | In distribution |
| 100122 | Outer Diameter 9.0 mm | In distribution |
| 100136-055 | Outer Diameter 5.5 mm | In distribution |
| 100220-C-7570 | Outer Diameter 7.5 mm | In distribution |
| 100220-S-8560 | Outer Diameter 8.5 mm | In distribution |
| 100220-S-6540 | Outer Diameter 6.5 mm | In distribution |
| 100235-8555 | 8.5mm diameter | In distribution |
| 100136-050 | Outer Diameter 5.5 mm | In distribution |
| 100136-110 | Outer Diameter 5.5 mm | In distribution |
| 100220-C-8570 | Outer Diameter 8.5 mm | In distribution |
| 100235-7555 | 7.5mm diameter | In distribution |
| 100136-260 | Outer Diameter 5.5 mm | In distribution |
| 100020-090 | Outer Diameter 5.5 mm | In distribution |
| 100136-160 | Outer Diameter 5.5 mm | In distribution |
| 100220-S-85110 | Outer Diameter 8.5 mm | In distribution |
| 100235-8535 | 8.5mm diameter | In distribution |
| 100220-C-75110 | Outer Diameter 7.5 mm | In distribution |
| 100235-8560 | 8.5mm diameter | In distribution |
| 100256 | In distribution | |
| 100020-025 | Outer Diameter 5.5 mm | In distribution |
| 100220-S-9055 | Outer Diameter 9.0 mm | In distribution |
| 100136-220 | Outer Diameter 5.5 mm | In distribution |
| 100235-75110 | 7.5mm diameter | In distribution |
| 100220-S-5535 | Outer Diameter 5.5 mm | In distribution |
| 100208-6550 | 6.5mm diameter | In distribution |
| 100135-040 | Outer Diameter 5.5 mm | In distribution |
| 100220-C-6540 | Length 40 mm | In distribution |
| 100235-7590 | 7.5mm diameter | In distribution |
| 100012-0001 | 35 – 40 mm | In distribution |
| 100220-C-6560 | Length 60 mm | In distribution |
| 100220-C-7555 | Length 55 mm | In distribution |
| 100020-070 | Outer Diameter 5.5 mm | In distribution |
| 100136-190 | Outer Diameter 5.5 mm | In distribution |
| 100135-100 | Outer Diameter 5.5 mm | In distribution |
| 100208-8545 | 8.5mm diameter | In distribution |
| 100135-045 | Outer Diameter 5.5 mm | In distribution |
| 100136-100 | Outer Diameter 5.5 mm | In distribution |
| 100135-090 | Outer Diameter 5.5 mm | In distribution |
| 100220-S-9045 | Outer Diameter 9.0 mm | In distribution |
| 100208-7590 | 7.5mm diameter | In distribution |
| 100220-S-8530 | Outer Diameter 8.5 mm | In distribution |
| 100235-8580 | 8.5mm diameter | In distribution |
| 100080-100 | Outer Diameter 5.5 mm | In distribution |
| 100208-7555 | 7.5mm diameter | In distribution |
| 100269 | In distribution | |
| 100220-C-9050 | Outer Diameter 9.0 mm | In distribution |
| 100136-070 | Outer Diameter 5.5 mm | In distribution |
| 100020-150 | Outer Diameter 5.5 mm | In distribution |
| 100136-180 | Outer Diameter 5.5 mm | In distribution |
| 100020-300 | Outer Diameter 5.5 mm | In distribution |
| 100220-S-6580 | Length 80 mm | In distribution |
| 100235-5540 | 5.5mm diameter | In distribution |
| 100012-0003 | 50 – 65mm | In distribution |
| 100235-6555 | 6.5mm diameter | In distribution |
| 100235-85100 | 8.5mm diameter | In distribution |
| 100220-S-8550 | Outer Diameter 8.5 mm | In distribution |
| 100235-8570 | 8.5mm diameter | In distribution |
| 100020-450 | Outer Diameter 5.5 mm | In distribution |
| 100135-200 | Outer Diameter 5.5 mm | In distribution |
| 100220-C-8540 | Length 40 mm | In distribution |
| 100135-170 | Outer Diameter 5.5 mm | In distribution |
| 100080-045 | Outer Diameter 5.5 mm | In distribution |
| 100220-C-7560 | Outer Diameter 7.5 mm | In distribution |
| 100220-S-85100 | Outer Diameter 8.5 mm | In distribution |
| 100273 | In distribution | |
| 100136-060 | Outer Diameter 5.5 mm | In distribution |
| 100251 | In distribution | |
| 100136-045 | Outer Diameter 5.5 mm | In distribution |
| 100080-140 | Outer Diameter 5.5 mm | In distribution |
| 100136-120 | Outer Diameter 5.5 mm | In distribution |
| 100136-140 | Outer Diameter 5.5 mm | In distribution |
| 100220-C-8535 | Length 35 mm | In distribution |
| 100235-6535 | 6.5mm diameter | In distribution |
| 100220-S-75110 | Outer Diameter 7.5 mm | In distribution |
| 100187-02 | In distribution | |
| 100135-050 | Outer Diameter 5.5 mm | In distribution |
| 100059 | Outer Diameter 9.0 mm | In distribution |
| 100136-090 | Outer Diameter 5.5 mm | In distribution |
| 100187-01 | In distribution | |
| 100136-150 | Outer Diameter 5.5 mm | In distribution |
| 100235-7580 | 7.5mm diameter | In distribution |
| 100220-C-6550 | Length 50 mm | In distribution |
| 100136-170 | Outer Diameter 5.5 mm | In distribution |
| 100220-C-6590 | Length 90 mm | In distribution |
| 100135-110 | Outer Diameter 5.5 mm | In distribution |
| 100135-140 | Outer Diameter 5.5 mm | In distribution |
| 100136-130 | Outer Diameter 5.5 mm | In distribution |
| 100220-S-6570 | Length 70 mm | In distribution |
| 100220-S-7555 | Outer Diameter 7.5 mm | In distribution |
| 100020-055 | Outer Diameter 5.5 mm | In distribution |
| 100136-075 | Outer Diameter 5.5 mm | In distribution |
| 100220-C-9060 | Outer Diameter 9.0 mm | In distribution |
| 100220-C-5535 | Length 35 mm | In distribution |
| 100235-85110 | 8.5mm diameter | In distribution |
| 100208-6540 | 6.5mm diameter | In distribution |
| 100235-5550 | 5.5mm diameter | In distribution |
| 100135-060 | Outer Diameter 5.5 mm | In distribution |
| 100208-4525 | 4.5mm diameter | Withdrawn |
| 100008-7555 | 7.5mm diameter | Withdrawn |
| 100208-4535 | 4.5mm diameter | Withdrawn |
| 100208-4545 | 4.5mm diameter | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 3,144 |
| Anax™ 5.5 Spinal System | CG MedTech Co., Ltd. | 2,177 |
| ReLine | Nuvasive, Inc. | 2,010 |
| Creo | Globus Medical, Inc. | 1,619 |
| Perfix™ Spinal System | CG MedTech Co., Ltd. | 1,476 |
| Apex Spine System | Spinecraft LLC | 1,193 |
| Olympic | Astura Medical | 1,173 |
| Arsenal | Alphatec Spine, Inc. | 1,001 |
| Revere | Globus Medical, Inc. | 997 |
| Astra Spine System | Spinecraft LLC | 798 |
| Apex-DL Spine System | Spinecraft LLC | 735 |
| Zenius Spinal System | Medyssey Co., Ltd. | 712 |
Showing 12 of 811. All products under Orthosis, Spondylolisthesis Spinal Fixation
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K150283 | 2015-04-29 |
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.