ST360°®
65 catalogue numbers from 07.00401.014, listed by Zimmer Spine, Inc., United States, under Orthosis, Spinal Pedicle Fixation. 13 manufacturers in China are registered for this product code.
13manufacturers in China registered for this device type
65catalogue 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, Spinal Pedicle Fixation
Record
| Listed by | Zimmer Spine, Inc., United States |
|---|---|
| FDA product code | MNI |
| Device type | Orthosis, Spinal Pedicle Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Record published | 2015-09-24 |
| Record revised | 2025-07-02 (version 8) |
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 |
| Sizes | Length 11 to 87.5 mm; outer diameter 4.5 to 9.5 mm; lumen/inner diameter 5.5 to 6.35 mm; length 4 to 20 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 07.00401.014 | Lumen/Inner Diameter 5.5 mm | In distribution |
| 07.00405.023 | Lumen/Inner Diameter 6.35 mm | In distribution |
| 07.00405.031 | Lumen/Inner Diameter 6.35 mm | In distribution |
| 07.00319.065 | Outer Diameter 9.5 mm | In distribution |
| 07.00292.007 | Length 5 cm | In distribution |
| 07.01084.001 | Outer Diameter 5.5 mm | In distribution |
| 07.00452.001 | In distribution | |
| 07.00857.011 | Outer Diameter 5.5 mm | In distribution |
| 07.00405.032 | Length 87.5 mm | In distribution |
| 07.00295.002 | (12 mm – 18 mm L) | In distribution |
| 07.00319.038 | Length 60 mm | In distribution |
| 07.00401.021 | Length 60 mm | In distribution |
| 07.00401.011 | Length 35 mm | In distribution |
| 07.00401.013 | Length 40 mm | In distribution |
| 07.00326.001 | (8 mm) | In distribution |
| 07.00405.030 | Length 82.5 mm | In distribution |
| 07.00401.028 | Lumen/Inner Diameter 5.5 mm | In distribution |
| 07.00319.016 | Outer Diameter 4.5 mm | In distribution |
| 07.00319.027 | Length 55 mm | In distribution |
| 07.00405.005 | Length 20 mm | In distribution |
| 07.00858.015 | Outer Diameter 6.35 mm | In distribution |
| 07.00298.004 | Length 5 cm | In distribution |
| 07.00319.058 | Outer Diameter 8.5 mm | In distribution |
| 07.00409.001 | Length 40.00 mm | In distribution |
| 07.00320.009 | Outer Diameter 5.5 mm | In distribution |
| 07.00433.001 | In distribution | |
| 07.00296.002 | Length 20 cm | In distribution |
| 07.00401.001 | Length 11 mm | In distribution |
| 07.00295.001 | (10 mm – 15 mm L) | In distribution |
| 07.00409.003 | Length 60.00 mm | In distribution |
| 07.00298.006 | Length 4.5 cm | In distribution |
| 07.00319.054 | Length 40 mm | In distribution |
| 07.00319.037 | Length 55 mm | In distribution |
| 07.00857.018 | Outer Diameter 5.5 mm | In distribution |
| 07.00319.011 | Length 25 mm | In distribution |
| 07.00424.001 | Lumen/Inner Diameter 5.5 mm | In distribution |
| 07.00319.039 | Outer Diameter 6.5 mm | In distribution |
| 07.00320.007 | Length 5.5 cm | In distribution |
| 07.00442.001 | In distribution | |
| 07.00319.024 | Outer Diameter 5.5 mm | In distribution |
| 07.00401.029 | Length 80 mm | In distribution |
| 07.00401.023 | Length 65 mm | In distribution |
| 07.00319.034 | Outer Diameter 6.5 mm | In distribution |
| 07.00401.026 | Lumen/Inner Diameter 5.5 mm | In distribution |
| 07.00450.001 | In distribution | |
| 07.00401.030 | Lumen/Inner Diameter 5.5 mm | In distribution |
| 07.00319.068 | Length 60 mm | In distribution |
| 07.00401.032 | Length 87.5 mm | In distribution |
| 07.00858.017 | Outer Diameter 6.35 mm | In distribution |
| 07.00405.015 | Length 45 mm | In distribution |
| 07.00443.001 | In distribution | |
| 07.00320.006 | Outer Diameter 5.5 mm | In distribution |
| 07.00858.010 | Length 44 mm | In distribution |
| 07.01084.006 | Outer Diameter 5.5 mm | In distribution |
| 07.00319.053 | Length 35 mm | In distribution |
| 07.00425.001 | Lumen/Inner Diameter 6.35 mm | In distribution |
| 07.00319.031 | Length 25 mm | In distribution |
| 07.00857.013 | Outer Diameter 5.5 mm | In distribution |
| 07.00401.002 | Length 13 mm | In distribution |
| 07.00298.002 | Length 8 cm | In distribution |
| 07.00405.020 | Lumen/Inner Diameter 6.35 mm | In distribution |
| 07.00405.025 | Length 70 mm | In distribution |
| 07.00858.012 | Outer Diameter 6.35 mm | In distribution |
| 07.00292.001 | Length 10 cm | In distribution |
| 07.00292.010 | Outer Diameter 6.35 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 2,342 |
| Creo | Globus Medical, Inc. | 1,784 |
| ReLine | Nuvasive, Inc. | 1,718 |
| AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 1,525 |
| Apex Spine System | Spinecraft LLC | 1,114 |
| Revere | Globus Medical, Inc. | 1,051 |
| LnK Spinal Fixation System | L&K Biomed Co., Ltd. | 974 |
| LnK Basic Spinal Fixation System | L&K Biomed Co., Ltd. | 935 |
| Arsenal | Alphatec Spine, Inc. | 932 |
| Zavation | Zavation | 864 |
| Polaris™ 5.5 Spinal System | Biomet Spine | 809 |
| Apex-DL Spine System | Spinecraft LLC | 792 |
Showing 12 of 950. All products under Orthosis, Spinal Pedicle Fixation
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K071880 | 2007-10-05 |
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.