M.u.s.t. Rods
Enh. Bent Rod CoCr R100 5.5x150mm - Sterile
13manufacturers in China registered for this device type
54catalogue 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 | Medacta International SA, Switzerland |
|---|---|
| FDA product code | MNI |
| Device type | Orthosis, Spinal Pedicle Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Specification developer, Repacker / relabeller, Private-label distributor, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K141988 |
| Record published | 2014-09-17 |
| Record revised | 2024-09-17 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 03.52.555 | In distribution | |
| 03.52.501 | In distribution | |
| 03.52.559 | In distribution | |
| 03.52.405 | In distribution | |
| 03.52.488 | In distribution | |
| 03.52.435 | In distribution | |
| 03.52.474 | In distribution | |
| 03.50.431 | In distribution | |
| 03.52.466 | In distribution | |
| 03.52.507 | In distribution | |
| 03.52.470 | In distribution | |
| 03.52.423 | In distribution | |
| 03.52.557 | In distribution | |
| 03.52.454 | In distribution | |
| 03.52.429 | In distribution | |
| 03.52.464 | In distribution | |
| 03.52.414 | In distribution | |
| 03.52.425 | In distribution | |
| 03.52.460 | In distribution | |
| 03.52.503 | In distribution | |
| 03.52.401 | In distribution | |
| 03.52.411 | In distribution | |
| 03.52.565 | In distribution | |
| 03.50.433 | In distribution | |
| 03.50.401 | In distribution | |
| 03.52.433 | In distribution | |
| 03.52.462 | In distribution | |
| 03.52.416 | In distribution | |
| 03.52.421 | In distribution | |
| 03.52.456 | In distribution | |
| 03.52.431 | In distribution | |
| 03.52.561 | In distribution | |
| 03.52.553 | In distribution | |
| 03.52.458 | In distribution | |
| 03.52.409 | In distribution | |
| 03.52.546 | In distribution | |
| 03.50.403 | In distribution | |
| 03.52.563 | In distribution | |
| 03.52.505 | In distribution | |
| 03.52.576 | In distribution | |
| 03.52.438 | In distribution | |
| 03.52.509 | In distribution | |
| 03.52.568 | In distribution | |
| 03.52.427 | In distribution | |
| 03.52.551 | In distribution | |
| 03.52.514 | In distribution | |
| 03.52.446 | In distribution | |
| 03.52.403 | In distribution | |
| 03.52.516 | In distribution | |
| 03.52.452 | In distribution | |
| 03.52.442 | In distribution | |
| 03.52.572 | In distribution | |
| 03.52.407 | In distribution | |
| 03.52.511 | 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 |
|---|---|
| K132788 | 2014-05-23 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Medacta Usa Inc | 510(k) number | 2016-12-07 | Class II | Packaging | Damaged packaging, lack of sterility assurance | 82 units | 2017-11-15 |
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.