MIS Golden Isles Pedicle Screw System
MIS Provisional Locking Cap Driver
15manufacturers in China registered for this device type
47catalogue numbers in this listing
1510(k) clearance
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 | Intelivation Technologies, LLC, United States |
|---|---|
| FDA product code | NKB |
| Device type | Thoracolumbosacral Pedicle Screw System |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2023-04-27 |
| Record revised | 2026-01-30 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, manufacturing date |
| Sizes | Length 30 to 250 mm; outer diameter 5.5 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| C25-200A-055 | Length 55 mm | In distribution |
| C25-200A-050 | Length 50 mm | In distribution |
| C50-8000-021 | In distribution | |
| C25-200A-150 | Length 150 mm | In distribution |
| C50-3000-009 | In distribution | |
| C25-200A-220 | Length 220 mm | In distribution |
| C25-200A-250 | Length 250 mm | In distribution |
| C25-200A-120 | Length 120 mm | In distribution |
| C50-8000-005 | In distribution | |
| C25-200A-075 | Length 75 mm | In distribution |
| C51-1000-A03 | In distribution | |
| C25-200A-170 | Length 170 mm | In distribution |
| C50-8000-001 | In distribution | |
| C25-200A-180 | Length 180 mm | In distribution |
| C25-200A-100 | Length 100 mm | In distribution |
| C50-8000-003 | In distribution | |
| C25-200A-035 | Length 35 mm | In distribution |
| C25-200A-230 | Length 230 mm | In distribution |
| C50-8000-007 | In distribution | |
| C50-8000-004 | In distribution | |
| C25-200A-095 | Length 95 mm | In distribution |
| C25-200A-190 | Length 190 mm | In distribution |
| C50-8000-016 | In distribution | |
| C50-8000-006 | In distribution | |
| C25-200A-200 | Length 200 mm | In distribution |
| C50-8000-011 | In distribution | |
| C50-8000-022 | In distribution | |
| C25-200A-030 | Length 30 mm | In distribution |
| C25-200A-140 | Length 140 mm | In distribution |
| C25-200A-110 | Length 110 mm | In distribution |
| C51-1000-A02 | In distribution | |
| C25-200A-080 | Length 80 mm | In distribution |
| C50-8000-001 | In distribution | |
| C25-200A-040 | Length 40 mm | In distribution |
| C51-1000-A01 | In distribution | |
| C25-200A-210 | Length 210 mm | In distribution |
| C25-200A-240 | Length 240 mm | In distribution |
| C25-200A-090 | Length 90 mm | In distribution |
| C50-8000-008 | In distribution | |
| C25-200A-085 | Length 85 mm | In distribution |
| C25-200A-160 | Length 160 mm | In distribution |
| C50-8000-022 | Length 45 mm | In distribution |
| C25-200A-030 | Length 30 mm | In distribution |
| C25-200A-045 | Length 45 mm | In distribution |
| C25-200A-130 | Length 130 mm | In distribution |
| C50-8000-002 | In distribution | |
| C25-200A-060 | Length 60 mm | In distribution |
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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K212185 | 2021-08-19 |
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.