Revolve
5.5mm REVOLVE Rod, CoCr, Extra Lordotic, 100mm
11manufacturers in China registered for this device type
56catalogue numbers in this listing
7510(k) clearances naming this product code
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 | Globus Medical, Inc., United States |
|---|---|
| FDA product code | KWP |
| Device type | Appliance, Fixation, Spinal Interlaminal |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3050 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K111449 |
| Record published | 2015-10-28 |
| Record revised | 2025-07-02 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Label carries | lot or batch number |
| Sizes | Length 25 to 450 mm; outer diameter 5 to 8.5 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 785.650 | Length 450 mm | In distribution |
| 185.445 | Outer Diameter 5 mm | In distribution |
| 185.084 | Length 85 mm | In distribution |
| 585.346 | Length 50 mm | In distribution |
| 785.540 | Length 340 mm | In distribution |
| 785.900 | Length 100 mm | In distribution |
| 785.270 | Length 70 mm | In distribution |
| 185.480 | Length 280 mm | In distribution |
| 785.320 | Length 120 mm | In distribution |
| 785.520 | Length 320 mm | In distribution |
| 185.463 | Outer Diameter 6.5 mm | In distribution |
| 585.243 | Length 35 mm | In distribution |
| 185.510 | Length 310 mm | In distribution |
| 785.470 | Length 270 mm | In distribution |
| 585.356 | Outer Diameter 5.5 mm | In distribution |
| 585.151 | Length 25 mm | In distribution |
| 785.290 | Length 90 mm | In distribution |
| 185.245 | Length 45 mm | In distribution |
| 785.430 | Length 230 mm | In distribution |
| 185.451 | Outer Diameter 5.5 mm | In distribution |
| 585.387 | Outer Diameter 8.5 mm | In distribution |
| 185.500 | Length 300 mm | In distribution |
| 785.330 | Length 130 mm | In distribution |
| 585.345 | Outer Diameter 5 mm | In distribution |
| 785.265 | Length 65 mm | In distribution |
| 185.482 | Outer Diameter 8.5 mm | In distribution |
| 785.255 | Length 55 mm | In distribution |
| 185.468 | Length 60 mm | In distribution |
| 185.473 | Outer Diameter 7.5 mm | In distribution |
| 585.392 | Length 80 mm | In distribution |
| 185.416 | Length 95 mm | In distribution |
| 585.384 | Outer Diameter 8.5 mm | In distribution |
| 185.489 | Outer Diameter 8.5 mm | In distribution |
| 185.441 | Outer Diameter 5 mm | In distribution |
| 785.600 | Length 400 mm | In distribution |
| 585.365 | Outer Diameter 6.5 mm | In distribution |
| 185.450 | Length 250 mm | In distribution |
| 785.240 | Length 40 mm | In distribution |
| 585.165 | Outer Diameter 6.5 mm | In distribution |
| 785.390 | Length 190 mm | In distribution |
| 585.344 | Outer Diameter 5 mm | In distribution |
| 185.930 | Length 130 mm | In distribution |
| 185.880 | Length 80 mm | In distribution |
| 185.408 | Length 105 mm | In distribution |
| 185.460 | Length 260 mm | In distribution |
| 185.461 | Outer Diameter 6.5 mm | In distribution |
| 585.147 | Outer Diameter 5 mm | In distribution |
| 185.380 | Length 180 mm | In distribution |
| 185.464 | Length 40 mm | In distribution |
| 585.347 | Outer Diameter 5 mm | In distribution |
| 585.241 | Length 25 mm | In distribution |
| 785.280 | Length 80 mm | In distribution |
| 585.263 | Length 35 mm | In distribution |
| 785.310 | Length 110 mm | In distribution |
| 185.600 | Length 400 mm | In distribution |
| 585.379 | Outer Diameter 7.5 mm | 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 |
|---|---|
| K123783 | 2013-03-14 |
| K110963 | 2011-05-05 |
| K102195 | 2011-01-19 |
| K090565 | 2009-06-30 |
| K081906 | 2008-11-14 |
| K052069 | 2005-08-17 |
| K050391 | 2005-07-21 |
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.