Streamline OCT
Polyaxial Screw, Smooth Shank, 4.0 X 32mm
4manufacturers in China registered for this device type
126catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (1), Shandong (1), Fujian (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| 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 | NKG |
| Device type | Posterior Cervical Screw System |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3075 |
| 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-PA-SS-40-32 | In distribution | |
| 26-OCPST-525-16 | In distribution | |
| 26-OCPPLATE | In distribution | |
| 26-3255-CLSD-11 | In distribution | |
| 26-HA-40-44 | In distribution | |
| 26-HA-35-10 | In distribution | |
| 26-PA-35-10 | In distribution | |
| 26-PA-35-18 | In distribution | |
| 26-H2H-XLINK-XL | In distribution | |
| 26-HA-35-22 | In distribution | |
| 26-PA-40-44 | In distribution | |
| 26-OCPST-525-11 | In distribution | |
| 26-OCPS-45-16 | In distribution | |
| 26-PA-35-26 | In distribution | |
| 26-OCPS-525-12 | In distribution | |
| 26-PA-40-10 | In distribution | |
| 26-CC-PB-ROD-105 | In distribution | |
| 26-HA-35-46 | In distribution | |
| 26-R2R-XLINK-XL | In distribution | |
| 26-OCPCONNECTOR-17 | In distribution | |
| 26-PA-35-34 | In distribution | |
| 26-OCPS-45-9 | In distribution | |
| 26-OCPST-45-10 | In distribution | |
| 23-CC-ROD-50 | In distribution | |
| 26-PA-SS-40-36 | In distribution | |
| 26-PA-SS-40-34 | In distribution | |
| 23-L-CAP | In distribution | |
| 26-PA-45-16 | In distribution | |
| 26-PA-SS-40-38 | In distribution | |
| 23-CC-ROD-30 | In distribution | |
| 26-OCPS-525-7 | In distribution | |
| 23-SSCON-32-55 | In distribution | |
| 26-HA-35-42 | In distribution | |
| 26-OCPST-525-15 | In distribution | |
| 26-3255-OPEN-11 | In distribution | |
| 26-PA-SS-35-40 | In distribution | |
| 26-HA-35-34 | In distribution | |
| 26-PA-40-48 | In distribution | |
| 26-OCPS-525-16 | In distribution | |
| 23-CC-ROD-110 | In distribution | |
| 26-CC-PB-ROD-30 | In distribution | |
| 26-OCPS-45-14 | In distribution | |
| 26-HA-40-46 | In distribution | |
| 26-PA-35-30 | In distribution | |
| 23-VAR-CRSSLNK-L | In distribution | |
| 26-HA-35-26 | In distribution | |
| 26-PA-35-28 | In distribution | |
| 26-HA-40-36 | In distribution | |
| 23-CC-ROD-90 | In distribution | |
| 26-PA-45-40 | In distribution | |
| 26-CC-PB-ROD-35 | In distribution | |
| 26-HA-40-24 | In distribution | |
| 26-PA-35-14 | In distribution | |
| 26-HA-35-36 | In distribution | |
| 26-CC-TRANS-ROD | In distribution | |
| 26-PA-SS-35-20 | In distribution | |
| 26-OCPCONNECTOR-14 | In distribution | |
| 26-PA-35-24 | In distribution | |
| 23-CC-ROD-100 | In distribution | |
| 26-PA-35-44 | In distribution | |
| 26-PA-40-18 | In distribution | |
| 26-PA-40-16 | In distribution | |
| 26-H2H-XLINK-L | In distribution | |
| 23-CC-ROD-120 | In distribution | |
| 26-PA-45-44 | In distribution | |
| 26-PA-SS-40-42 | In distribution | |
| 26-PA-35-48 | In distribution | |
| 26-OCPST-525-10 | In distribution | |
| 26-OCPST-525-14 | In distribution | |
| 26-HA-40-50 | In distribution | |
| 23-CC-ROD-70 | In distribution | |
| 26-CC-TRANS-ROD-XL | In distribution | |
| 26-PA-35-32 | In distribution | |
| 26-PA-45-20 | In distribution | |
| 26-OFFSETCONN-A | In distribution | |
| 26-HA-35-24 | In distribution | |
| 26-OCPS-525-14 | In distribution | |
| 26-R2R-XLINK-L | In distribution | |
| 26-PA-45-15 | In distribution | |
| 26-HA-35-50 | In distribution | |
| 26-PA-SS-35-42 | In distribution | |
| 26-H2H-SETSCREW | In distribution | |
| 26-OCPS-525-11 | In distribution | |
| 26-OCPST-45-14 | In distribution | |
| 26-PA-45-32 | In distribution | |
| 26-PA-SS-35-30 | In distribution | |
| 26-OCPS-45-11 | In distribution | |
| 26-HA-35-28 | In distribution | |
| 26-CC-PB-ROD-65 | In distribution | |
| 26-HA-40-26 | In distribution | |
| 26-OCPS-525-15 | In distribution | |
| 26-PA-35-12 | In distribution | |
| 26-CC-PB-ROD-50 | In distribution | |
| 26-PA-40-24 | In distribution | |
| 26-PA-45-34 | In distribution | |
| 26-OCP-ASSY-17 | In distribution | |
| 26-PA-45-25 | In distribution | |
| 26-HA-35-12 | In distribution | |
| 26-PA-40-32 | In distribution | |
| 26-PA-35-46 | In distribution | |
| 26-HA-35-32 | In distribution | |
| 26-CC-PB-ROD-100 | In distribution | |
| 26-HA-40-32 | In distribution | |
| 26-CC-PB-ROD-95 | In distribution | |
| 26-OCPS-45-7 | In distribution | |
| 23-CC-ROD-180 | In distribution | |
| 23-CC-ROD-160 | In distribution | |
| 26-PA-45-45 | In distribution | |
| 23-VAR-CRSSLNK-M | In distribution | |
| 26-OCPCONNECTOR-20 | In distribution | |
| 26-OCPS-45-13 | In distribution | |
| 26-PA-SS-40-30 | In distribution | |
| 26-PA-40-22 | In distribution | |
| 26-PA-SS-40-40 | In distribution | |
| 26-H2H-XLINK-S | In distribution | |
| 26-3255-INLINE-11 | In distribution | |
| 26-PA-SS-40-44 | In distribution | |
| 26-OCPS-525-8 | In distribution | |
| 26-PA-45-26 | In distribution | |
| 23-CC-ROD-360 | In distribution | |
| 26-OCPS-45-15 | In distribution | |
| 26-CC-PB-ROD-90 | In distribution | |
| 26-PA-45-36 | In distribution | |
| 26-OCPST-525-13 | In distribution | |
| 26-CC-PB-ROD-115 | In distribution | |
| 26-PA-40-46 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Bridalveil | Astura Medical | 1,718 |
| Proficient™ Posterior Cervical Spine System | Spine Wave, Inc. | 1,590 |
| Invictus | Alphatec Spine, Inc. | 1,538 |
| Paeon Posterior Cervical Fixation System | Aegis Spine | 1,408 |
| ReLine | Nuvasive, Inc. | 1,072 |
| PathLoc-C Posterior Cervical Fixation System | L&K Biomed Co., Ltd. | 706 |
| Cosy | Signus Medizintechnik Gmbh | 550 |
| Yukon OCT Spinal System | VB Spine LLC | 451 |
| Astra-OCT Spine System | Spinecraft LLC | 440 |
| Symphony | Medos International Sàrl | 389 |
| Medyssey Poseidon OCT Spinal Fixation System | Medyssey Co., Ltd. | 387 |
| Infinity™ Occipitocervical Upper Thoracic System | Medtronic Sofamor Danek, Inc. | 375 |
Showing 12 of 336. All products under Posterior Cervical Screw System
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.