Streamline OCT
Polyaxial Screw, Smooth Shank, 3.5 X 32mm
11manufacturers in China registered for this device type
120catalogue 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 | Xtant Medical Holdings, Inc., United States |
|---|---|
| FDA product code | KWP |
| Device type | Appliance, Fixation, Spinal Interlaminal |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3050 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K172139 |
| Record published | 2023-10-05 |
| Record revised | 2025-07-02 (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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 26-HA-40-40 | In distribution | |
| 26-HA-40-42 | In distribution | |
| 26-PA-40-34 | In distribution | |
| 26-OCPS-45-10 | In distribution | |
| 26-OCPST-45-13 | In distribution | |
| 26-HA-35-20 | In distribution | |
| 26-PA-45-28 | In distribution | |
| 26-CC-PB-ROD-85 | In distribution | |
| 26-OCPST-45-11 | In distribution | |
| 26-PA-45-48 | In distribution | |
| 26-3232-CLSD-11 | In distribution | |
| 23-VAR-CRSSLNK-S | In distribution | |
| 23-CC-ROD-210 | In distribution | |
| 26-CC-PB-ROD-75 | In distribution | |
| 26-HA-40-22 | In distribution | |
| 26-HA-35-18 | In distribution | |
| 26-R2R-XLINK-S | In distribution | |
| 26-PA-SS-35-32 | In distribution | |
| 26-PA-35-40 | In distribution | |
| 26-PA-SS-35-44 | In distribution | |
| 26-PA-40-30 | In distribution | |
| 26-PA-SS-35-46 | In distribution | |
| 23-CC-ROD-240 | In distribution | |
| 26-PA-45-12 | In distribution | |
| 23-CC-ROD-20 | In distribution | |
| 26-OFFSETCONN-S | In distribution | |
| 26-H2H-XLINK-XXL | In distribution | |
| 26-PA-45-18 | In distribution | |
| 26-R2R-XLINK-M | In distribution | |
| 26-HA-40-12 | In distribution | |
| 26-CC-PB-ROD-70 | In distribution | |
| 26-HA-40-28 | In distribution | |
| 26-PA-45-46 | In distribution | |
| 26-PA-SS-40-46 | In distribution | |
| 26-PA-SS-35-28 | In distribution | |
| 26-PA-45-10 | In distribution | |
| 26-OCPS-45-12 | In distribution | |
| 26-PA-SS-35-38 | In distribution | |
| 26-OCPST-45-16 | In distribution | |
| 26-PA-SS-40-28 | In distribution | |
| 26-PA-40-42 | In distribution | |
| 26-PA-35-20 | In distribution | |
| 26-CC-PB-ROD-55 | In distribution | |
| 26-PA-45-14 | In distribution | |
| 26-OCPST-45-15 | In distribution | |
| 26-PA-SS-35-36 | In distribution | |
| 26-HA-40-48 | In distribution | |
| 26-PA-40-14 | In distribution | |
| 26-PA-40-12 | In distribution | |
| 26-PA-40-26 | In distribution | |
| 26-HA-35-44 | In distribution | |
| 26-H2H-LOCKINGNUT | In distribution | |
| 26-PA-45-38 | In distribution | |
| 26-HOOK-S-5 | In distribution | |
| 26-PA-SS-40-22 | In distribution | |
| 26-OCP-ASSY-20 | In distribution | |
| 26-PA-SS-40-24 | In distribution | |
| 26-3255-CLSD-21 | In distribution | |
| 26-HA-40-30 | In distribution | |
| 26-HA-35-30 | In distribution | |
| 26-OCPS-45-6 | In distribution | |
| 26-OCPS-525-9 | In distribution | |
| 26-OCP-ASSY-08 | In distribution | |
| 26-PA-45-35 | In distribution | |
| 26-OCPS-45-8 | In distribution | |
| 26-PA-SS-40-48 | In distribution | |
| 26-PA-SS-35-26 | In distribution | |
| 26-CC-PB-ROD-80 | In distribution | |
| 26-HA-35-14 | In distribution | |
| 26-PA-SS-35-22 | In distribution | |
| 26-HA-40-38 | In distribution | |
| 26-CC-PB-ROD-120 | In distribution | |
| 26-PA-SS-35-48 | In distribution | |
| 26-PA-40-28 | In distribution | |
| 26-PA-45-42 | In distribution | |
| 26-PA-40-20 | In distribution | |
| 26-CC-PB-ROD-40 | In distribution | |
| 26-PA-40-36 | In distribution | |
| 26-CC-PB-ROD-60 | In distribution | |
| 26-H2H-XLINK-M | In distribution | |
| 26-PA-40-40 | In distribution | |
| 26-HA-40-34 | In distribution | |
| 26-OCPS-525-6 | In distribution | |
| 26-HA-35-38 | In distribution | |
| 26-HA-35-16 | In distribution | |
| 26-R2R-XLINK-XXL | In distribution | |
| 26-HA-35-40 | In distribution | |
| 26-H2H-XLINK-XS | In distribution | |
| 23-VAR-CRSLNK-XS | In distribution | |
| 26-OCP-ASSY-14 | In distribution | |
| 26-PA-SS-35-24 | In distribution | |
| 26-OCPST-45-12 | In distribution | |
| 26-PA-45-30 | In distribution | |
| 26-CC-PB-ROD-45 | In distribution | |
| 26-HA-40-20 | In distribution | |
| 23-CC-ROD-40 | In distribution | |
| 26-OCPST-525-12 | In distribution | |
| 26-PA-SS-35-34 | In distribution | |
| 26-PA-35-36 | In distribution | |
| 26-PA-35-38 | In distribution | |
| 26-SETSCREW | In distribution | |
| 26-HA-40-14 | In distribution | |
| 26-HA-40-18 | In distribution | |
| 26-PA-40-38 | In distribution | |
| 26-OCPS-525-10 | In distribution | |
| 26-OCPS-525-13 | In distribution | |
| 26-PA-SS-40-20 | In distribution | |
| 26-HA-40-10 | In distribution | |
| 26-CC-PB-ROD-110 | In distribution | |
| 26-HA-35-48 | In distribution | |
| 26-HA-40-16 | In distribution | |
| 26-PA-SS-40-26 | In distribution | |
| 26-PA-45-24 | In distribution | |
| 26-PA-35-22 | In distribution | |
| 26-PA-45-22 | In distribution | |
| 23-CC-ROD-60 | In distribution | |
| 26-PA-35-16 | In distribution | |
| 26-PA-35-42 | In distribution | |
| 26-HOOK-S-7 | In distribution | |
| 23-CC-ROD-80 | 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.