M.u.s.t. Rods
Enh. Dual Bend Rod CoCr 5.5x80mm - Sterile
11manufacturers in China registered for this device type
35catalogue 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 | Medacta International SA, Switzerland |
|---|---|
| FDA product code | KWP |
| Device type | Appliance, Fixation, Spinal Interlaminal |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3050 |
| Establishment | Specification developer, Repacker / relabeller, Private-label distributor, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K121115 |
| 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 |
|---|---|---|
| 03.50.462 | In distribution | |
| 03.50.475 | In distribution | |
| 03.50.450 | In distribution | |
| 03.50.453 | In distribution | |
| 03.50.457 | In distribution | |
| 03.50.471 | In distribution | |
| 03.50.458 | In distribution | |
| 03.50.451 | In distribution | |
| 03.50.455 | In distribution | |
| 03.50.478 | In distribution | |
| 03.50.479 | In distribution | |
| 03.52.492 | In distribution | |
| 03.50.459 | In distribution | |
| 03.50.461 | In distribution | |
| 03.50.480 | In distribution | |
| 03.50.400 | In distribution | |
| 03.50.460 | In distribution | |
| 03.50.474 | In distribution | |
| 03.50.481 | In distribution | |
| 03.52.592 | In distribution | |
| 03.50.477 | In distribution | |
| 03.50.472 | In distribution | |
| 03.50.402 | In distribution | |
| 03.50.454 | In distribution | |
| 03.50.473 | In distribution | |
| 03.50.482 | In distribution | |
| 03.50.476 | In distribution | |
| 03.50.452 | In distribution | |
| 03.50.463 | In distribution | |
| 03.50.483 | In distribution | |
| 03.52.588 | In distribution | |
| 03.50.432 | In distribution | |
| 03.50.456 | In distribution | |
| 03.50.470 | In distribution | |
| 03.50.430 | In distribution |
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 |
|---|---|
| K121115 | 2012-07-18 |
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.