Xia® 3 System – Serrato®
4826195120V
11manufacturers in China registered for this device type
58catalogue numbers in this listing
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 | VB Spine LLC |
|---|---|
| FDA product code | KWP |
| Device type | Appliance, Fixation, Spinal Interlaminal |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3050 |
| Record published | 2026-07-24 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Sizes | Length 10 to 100 mm; outer diameter 4 to 10 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 482614025V | Length 25 mm | In distribution |
| 489617530V | Outer Diameter 7.5 mm | In distribution |
| 489615555V | Outer Diameter 5.5 mm | In distribution |
| 482616030V | Length 30 mm | In distribution |
| 482611545V | Length 45 mm | In distribution |
| 482619570V | Outer Diameter 9.5 mm | In distribution |
| 482617060V | Outer Diameter 7 mm | In distribution |
| 482615025V | Outer Diameter 5 mm | In distribution |
| 482611590V | Outer Diameter 10 mm | In distribution |
| 4826195120V | Outer Diameter 9.5 mm | In distribution |
| 482614040V | Outer Diameter 4 mm | In distribution |
| 482619580V | Length 80 mm | In distribution |
| 482625545V | Length 45 mm | In distribution |
| 482616540V | Length 40 mm | In distribution |
| 489616550V | Length 50 mm | In distribution |
| 489616530V | Outer Diameter 6.5 mm | In distribution |
| 482615540V | Outer Diameter 5.5 mm | In distribution |
| 482616055V | Length 55 mm | In distribution |
| 482617560V | Outer Diameter 7.5 mm | In distribution |
| 482618580V | Length 80 mm | In distribution |
| 482615050V | Length 50 mm | In distribution |
| 482616550V | Outer Diameter 6.5 mm | In distribution |
| 482617540V | Length 40 mm | In distribution |
| 482627540V | Outer Diameter 7.5 mm | In distribution |
| 482625535V | Outer Diameter 5.5 mm | In distribution |
| 482614525V | Length 25 mm | In distribution |
| 482618545V | Outer Diameter 8.5 mm | In distribution |
| 482618555V | Outer Diameter 8.5 mm | In distribution |
| 482618540V | Outer Diameter 8.5 mm | In distribution |
| 482619560V | Outer Diameter 9.5 mm | In distribution |
| 482616045V | Length 45 mm | In distribution |
| 482615530V | Outer Diameter 5.5 mm | In distribution |
| 489616555V | Outer Diameter 6.5 mm | In distribution |
| 482627535V | Outer Diameter 7.5 mm | In distribution |
| 482611550V | Length 50 mm | In distribution |
| 489617550V | Outer Diameter 7.5 mm | In distribution |
| 482618570V | Outer Diameter 8.5 mm | In distribution |
| 482677590V | Length 90 mm | In distribution |
| 482616025V | Outer Diameter 6 mm | In distribution |
| 482627545V | Outer Diameter 7.5 mm | In distribution |
| 482616580V | Length 80 mm | In distribution |
| 482626560V | Length 60 mm | In distribution |
| 482626555V | Length 55 mm | In distribution |
| 4826165100V | Length 100 mm | In distribution |
| 489615535V | Outer Diameter 5.5 mm | In distribution |
| 482615020V | Outer Diameter 5 mm | In distribution |
| 482614540V | Outer Diameter 4.5 mm | In distribution |
| 482616525V | Outer Diameter 6.5 mm | In distribution |
| 482615040V | Length 40 mm | In distribution |
| 482614045V | Outer Diameter 4 mm | In distribution |
| 482618565V | Length 65 mm | In distribution |
| 4826185130V | Length 30 mm | In distribution |
| 482617040V | Outer Diameter 7 mm | In distribution |
| 4826185110V | Outer Diameter 8.5 mm | In distribution |
| 482616570V | Length 70 mm | In distribution |
| 4826115120V | Length 20 mm | In distribution |
| 489615540V | Outer Diameter 5.5 mm | In distribution |
| 489616560V | Outer Diameter 6.5 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
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.