Saxxony™ Posterior Cervical Thoracic System
R2R Connector, Double Open Wedding 3.5/5.5
11manufacturers in China registered for this device type
71catalogue 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 | Nexxt Spine LLC, United States |
|---|---|
| FDA product code | KWP |
| Device type | Appliance, Fixation, Spinal Interlaminal |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3050 |
| Establishment | Contract manufacturer, Complaint-file establishment, Manufacturer |
| 510(k) | K182508 |
| Record published | 2018-11-30 |
| Record revised | 2023-04-04 (version 4) |
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, serial number |
| Sizes | Length 10 to 400 mm; outer diameter 3 to 5.5 mm |
| Distribution end date | 2019-08-22 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| C12-02-12 | 4.5mm | In distribution |
| 12-PS-3514 | Length 14 mm | In distribution |
| 12-PS-5045 | Outer Diameter 5.0 mm | In distribution |
| 12-LC-01 | In distribution | |
| I12-320 | In distribution | |
| 12-AN-5325 | Length 25 mm | In distribution |
| 12-SS-4022 | Length 22 mm | In distribution |
| 12-SS-4042 | Length 42 mm | In distribution |
| 12-AN-3340 | Length 40 mm | In distribution |
| 12-SS-3540 | Length 40 mm | In distribution |
| I12-540 | Outer Diameter 4.0 mm | In distribution |
| 12-SS-3544 | Length 44 mm | In distribution |
| 12-PR-3540 | Length 40 mm | In distribution |
| 12-DS-35 | In distribution | |
| 12-SS-3532 | Length 32 mm | In distribution |
| 12-SR-35240 | Length 240 mm | In distribution |
| 12-SR-3570 | Length 70 mm | In distribution |
| 12-SS-4038 | Length 38 mm | In distribution |
| 12-TR-400 | Length 400 mm | In distribution |
| 12-PS-3518 | Length 18 mm | In distribution |
| 12-PS-3526 | Length 26 mm | In distribution |
| 12-PS-4525 | Outer Diameter 4.5 mm | In distribution |
| 12-PS-5035 | Outer Diameter 5.0 mm | In distribution |
| 12-PS-4535 | Outer Diameter 4.5 mm | In distribution |
| C12-02-10 | 3.5mm Long | In distribution |
| 12-PS-4030 | Outer Diameter 4.0 mm | In distribution |
| 12-SS-4018 | Length 18 mm | In distribution |
| 12-PS-3522 | Length 22 mm | In distribution |
| C12-02-11 | 4.0mm | In distribution |
| 12-HH-40 | In distribution | |
| 12-PS-4545 | Outer Diameter 4.5 mm | In distribution |
| 12-PR-3560 | Length 60 mm | In distribution |
| C12-01-02 | In distribution | |
| 12-PS-4022 | Outer Diameter 4.0 mm | In distribution |
| C12-02-08 | In distribution | |
| 12-SR-3550 | Length 50 mm | In distribution |
| 12-HH-30 | In distribution | |
| 12-RR-38 | In distribution | |
| C12-02-04 | In distribution | |
| 12-AN-3525 | Length 25 mm | In distribution |
| 12-PR-3520 | Length 20 mm | In distribution |
| 12-AN-3312 | Length 12 mm | In distribution |
| 12-SS-4026 | Length 26 mm | In distribution |
| 12-SS-4034 | Length 34 mm | In distribution |
| 12-PS-4026 | Outer Diameter 4.0 mm | In distribution |
| I12-550 | Outer Diameter 5.0 mm | In distribution |
| 12-PS-4016 | Length 16 mm | In distribution |
| 12-SS-3524 | Length 24 mm | In distribution |
| 12-SS-3536 | Length 36 mm | In distribution |
| 12-PS-4012 | Length 12 mm | In distribution |
| 12-SS-4030 | Length 30 mm | In distribution |
| 12-PR-3530 | Length 30 mm | In distribution |
| 12-RR-52 | In distribution | |
| 12-PS-4050 | Outer Diameter 4.0 mm | In distribution |
| 12-SS-3520 | Length 20 mm | In distribution |
| C12-02-09 | 3.5mm Short | In distribution |
| 12-EE-33 | In distribution | |
| 12-HH-50 | In distribution | |
| C12-02-13 | 3.5 & 4.0 Smooth | In distribution |
| 12-PR-3575 | Length 75 mm | In distribution |
| 12-DW-35 | In distribution | |
| 12-PS-4040 | Outer Diameter 4.0 mm | In distribution |
| I12-530 | Outer Diameter 3.0 mm | In distribution |
| 12-PS-3510 | Length 10 mm | In distribution |
| C12-02-06 | In distribution | |
| 12-SS-3528 | Length 28 mm | In distribution |
| 12-WD-35 | In distribution | |
| 12-PS-5030 | Outer Diameter 5.0 mm | In distribution |
| 12-LC-06 | In distribution | |
| I12-814 | Fixed | Withdrawn |
| I12-810 | Fixed | Withdrawn |
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.