Integrated Spine System
Diameter 6.0 mm x 60 mm Curved Spinal Rod Ti
11manufacturers in China registered for this device type
29catalogue numbers in this listing
1510(k) clearance
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 | Ortho Development Corp., United States |
|---|---|
| FDA product code | KWP |
| Device type | Appliance, Fixation, Spinal Interlaminal |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3050 |
| 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 4.75 to 8.5 mm; length 30 to 200 mm |
| Distribution end date | 2016-09-24 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 158-7535-01 | Outer Diameter 7.5 mm | Withdrawn |
| 158-1060 | Outer Diameter 6 mm | Withdrawn |
| 158-3065 | Length 65 mm | Withdrawn |
| 158-6070 | Withdrawn | |
| 158-8540-01 | Length 40 mm | Withdrawn |
| 158-3060 | Length 60 mm | Withdrawn |
| 158-7545-01 | Outer Diameter 7.5 mm | Withdrawn |
| 158-0040 | Length 40 mm | Withdrawn |
| 158-3030 | Outer Diameter 5.5 mm | Withdrawn |
| 158-1090 | Length 90 mm | Withdrawn |
| 158-6545-01 | Length 45 mm | Withdrawn |
| 158-3070 | Length 70 mm | Withdrawn |
| 158-5060 | Withdrawn | |
| 158-0070 | Length 70 mm | Withdrawn |
| 158-0090 | Outer Diameter 5.5 mm | Withdrawn |
| 158-7080 | Withdrawn | |
| 158-0075 | Length 75 mm | Withdrawn |
| 158-1075 | Outer Diameter 6 mm | Withdrawn |
| 158-0120 | Outer Diameter 5.5 mm | Withdrawn |
| 158-8535-01 | Outer Diameter 8.5 mm | Withdrawn |
| 158-4740-01 | Length 40 mm | Withdrawn |
| 158-4750-01 | Outer Diameter 4.75 mm | Withdrawn |
| 158-5545-01 | Length 45 mm | Withdrawn |
| 158-7580-01 | Length 80 mm | Withdrawn |
| 158-3200 | Outer Diameter 5.5 mm | Withdrawn |
| 158-0135 | Length 135 mm | Withdrawn |
| 158-4735-01 | Outer Diameter 4.75 mm | Withdrawn |
| 158-7550-01 | Outer Diameter 7.5 mm | Withdrawn |
| 158-3090 | Length 90 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K990986 | 1999-10-14 |
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.