Certex Spinal Fixation System
Special Instrument Certex, Screwdriver Assembly X067-0440 Modified
4manufacturers in China registered for this device type
55catalogue 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 |
| Record published | 2021-07-29 |
| Record revised | 2025-11-20 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Sizes | Length 12 to 400 mm; outer diameter 3.5 to 5.5 mm; width 24 mm |
| Distribution end date | 2024-12-16 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| C067-0051 | Withdrawn | |
| X067-1033 | Withdrawn | |
| X067-0466 | Outer Diameter 3.5 mm | Withdrawn |
| C067-0050 | Withdrawn | |
| C067-0042 | Withdrawn | |
| X067-0805 | Withdrawn | |
| X067-0009 | Withdrawn | |
| X067-0575 | Length 20 mm | Withdrawn |
| X067-0520 | Withdrawn | |
| X067-0710 | Withdrawn | |
| C067-0017 | Withdrawn | |
| X067-0500 | Withdrawn | |
| X067-1040 | Withdrawn | |
| X067-0573 | Length 16 mm | Withdrawn |
| C067-0035 | Withdrawn | |
| X067-0550 | Withdrawn | |
| C067-0002 | Withdrawn | |
| X067-0850 | Withdrawn | |
| C067-0047 | Withdrawn | |
| X067-0470 | Withdrawn | |
| C067-0011 | Withdrawn | |
| X067-1028 | Withdrawn | |
| X067-0574 | Length 18 mm | Withdrawn |
| X067-0651 | Outer Diameter 3.5 mm | Withdrawn |
| X067-0652 | Outer Diameter 5.5 mm | Withdrawn |
| X067-0007 | Withdrawn | |
| X067-0016 | Withdrawn | |
| X067-0875 | Withdrawn | |
| X067-1060 | Withdrawn | |
| X067-0572 | Length 14 mm | Withdrawn |
| X067-0017 | Withdrawn | |
| X067-0680 | Withdrawn | |
| X067-0530 | Withdrawn | |
| C067-0048 | Withdrawn | |
| C067-0041 | Withdrawn | |
| C067-0034 | Withdrawn | |
| X067-0006 | Withdrawn | |
| X067-0600 | Withdrawn | |
| X067-1035 | Withdrawn | |
| X067-0610 | Withdrawn | |
| X067-0008 | Withdrawn | |
| X067-0571 | Length 12 mm | Withdrawn |
| C067-0012 | Withdrawn | |
| X067-1034 | Withdrawn | |
| X067-0450 | Withdrawn | |
| X067-0640 | Withdrawn | |
| X067-0430 | Withdrawn | |
| X067-0630 | Withdrawn | |
| C067-0015 | Withdrawn | |
| X067-0465 | Withdrawn | |
| X067-0560 | Withdrawn | |
| X067-0003 | Withdrawn | |
| C067-0030 | Withdrawn | |
| X067-0005 | Withdrawn | |
| X067-1095 | Width 24 mm | Withdrawn |
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.