Integrated Spine System
Diameter 6.0 mm x 200 mm StraightSpinalRod Ti
13manufacturers in China registered for this device type
30catalogue 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 | Ortho Development Corp., United States |
|---|---|
| FDA product code | MNH |
| Device type | Orthosis, Spondylolisthesis Spinal Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K061524 |
| Record published | 2015-10-23 |
| Record revised | 2024-05-13 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Sizes | Outer diameter 5.5 to 8.5 mm; length 25 to 500 mm |
| Distribution end date | 2016-09-24 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 158-8530-01 | Outer Diameter 8.5 mm | Withdrawn |
| 158-6560-01 | Length 60 mm | Withdrawn |
| 158-8550-01 | Outer Diameter 8.5 mm | Withdrawn |
| 158-7540-01 | Outer Diameter 7.5 mm | Withdrawn |
| 158-3500 | Outer Diameter 5.5 mm | Withdrawn |
| 158-3050 | Outer Diameter 5.5 mm | Withdrawn |
| 158-6525-01 | Length 25 mm | Withdrawn |
| 158-5000-01 | Withdrawn | |
| 158-0150 | Length 150 mm | Withdrawn |
| 158-0035 | Outer Diameter 5.5 mm | Withdrawn |
| 158-3080 | Outer Diameter 5.5 mm | Withdrawn |
| 158-1050 | Outer Diameter 6 mm | Withdrawn |
| 158-0050 | Outer Diameter 5.5 mm | Withdrawn |
| 158-1080 | Outer Diameter 6 mm | Withdrawn |
| 158-3075 | Outer Diameter 5.5 mm | Withdrawn |
| 158-1200 | Length 200 mm | Withdrawn |
| 158-3040 | Length 40 mm | Withdrawn |
| 158-5550-01 | Length 50 mm | Withdrawn |
| 158-7560-01 | Outer Diameter 7.5 mm | Withdrawn |
| 158-1040 | Length 40 mm | Withdrawn |
| 158-0055 | Length 55 mm | Withdrawn |
| 158-7510-01 | Length 100 mm | Withdrawn |
| 158-3105 | Outer Diameter 5.5 mm | Withdrawn |
| 158-5525-01 | Length 25 mm | Withdrawn |
| 158-1055 | Outer Diameter 6 mm | Withdrawn |
| 158-3085 | Outer Diameter 5.5 mm | Withdrawn |
| 158-1065 | Outer Diameter 6 mm | Withdrawn |
| 158-8525-01 | Length 25 mm | Withdrawn |
| 158-6540-01 | Outer Diameter 6.5 mm | Withdrawn |
| 158-3055 | Outer Diameter 5.5 mm | 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 |
|---|---|
| K061524 | 2006-09-26 |
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.