Firebird
7.5MM X 110MM Modular Bone Screw Self-Tapping, Cannulated
4manufacturers in China registered for this device type
80catalogue numbers in this listing
2recalls on this code
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 | Orthofix US LLC, 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, Exporter |
| 510(k) | K171082 |
| Record published | 2018-05-24 |
| Record revised | 2026-02-20 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 77-8595 BE | In distribution | |
| 77-8660 BE | In distribution | |
| 77-8611 BE | In distribution | |
| 77-8680 BE | In distribution | |
| 77-8750 BE | In distribution | |
| 77-8775 BE | In distribution | |
| 77-8550 BE | In distribution | |
| 77-8545 BE | In distribution | |
| 77-8760 BE | In distribution | |
| 77-8655 BE | In distribution | |
| 77-8735 BE | In distribution | |
| 77-8510 BE | In distribution | |
| 44-5990 AF | In distribution | |
| 44-5860 BE | In distribution | |
| 44-5835 BE | In distribution | |
| 44-5825 BE | In distribution | |
| 77-8695 BE | In distribution | |
| 77-8535 BE | In distribution | |
| 77-8640 BE | In distribution | |
| 77-8670 BE | In distribution | |
| 77-8755 BE | In distribution | |
| 77-8675 BE | In distribution | |
| 44-5770 BE | In distribution | |
| 77-8790 BE | In distribution | |
| 44-5745 BE | In distribution | |
| 77-8711 BE | In distribution | |
| 77-8555 BE | In distribution | |
| 77-8575 BE | In distribution | |
| 44-5865 BE | In distribution | |
| 44-5885 BE | In distribution | |
| 44-5775 BE | In distribution | |
| 77-8635 BE | In distribution | |
| 44-5735 BE | In distribution | |
| 44-5855 BE | In distribution | |
| 77-8630 BE | In distribution | |
| 44-5870 BE | In distribution | |
| 77-8730 BE | In distribution | |
| 44-5755 BE | In distribution | |
| 44-5830 BE | In distribution | |
| 77-8710 BE | In distribution | |
| 44-5750 BE | In distribution | |
| 77-8770 BE | In distribution | |
| 44-5955 AF | In distribution | |
| 44-5875 BE | In distribution | |
| 44-5995 AF | In distribution | |
| 77-8685 BE | In distribution | |
| 44-5840 BE | In distribution | |
| 44-5795 BE | In distribution | |
| 77-8690 BE | In distribution | |
| 44-5740 BE | In distribution | |
| 77-8580 BE | In distribution | |
| 77-8590 BE | In distribution | |
| 44-5811 BE | In distribution | |
| 77-8565 BE | In distribution | |
| 44-5785 BE | In distribution | |
| 44-5725 BE | In distribution | |
| 77-8560 BE | In distribution | |
| 44-5850 BE | In distribution | |
| 77-8765 BE | In distribution | |
| 77-8650 BE | In distribution | |
| 44-5845 BE | In distribution | |
| 77-8540 BE | In distribution | |
| 44-5765 BE | In distribution | |
| 77-8665 BE | In distribution | |
| 44-5810 BE | In distribution | |
| 77-8745 BE | In distribution | |
| 77-8725 BE | In distribution | |
| 77-8525 BE | In distribution | |
| 44-5760 BE | In distribution | |
| 77-8785 BE | In distribution | |
| 77-8795 BE | In distribution | |
| 44-5730 BE | In distribution | |
| 77-8625 BE | In distribution | |
| 77-8740 BE | In distribution | |
| 44-5780 BE | In distribution | |
| 77-8610 BE | In distribution | |
| 44-5880 BE | In distribution | |
| 77-8780 BE | In distribution | |
| 44-5790 BE | In distribution | |
| 77-8530 BE | 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
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2018-02-23 | Class II | Nonconforming Material/Component | Orthofix is conducting a voluntary recall of the Connector System Large Set Screw (PN: 79-2002) with affected Lot Numbers 001 and 002, and Small Set Screw (PN: 79-2003) with affected Lot Numbers 002, 003 and 004. Through the company’s manuf | 188 units | 2019-06-18 |
| 2018-02-23 | Class II | Nonconforming Material/Component | Orthofix is conducting a voluntary recall of the Connector System Large Set Screw (PN: 79-2002) with affected Lot Numbers 001 and 002, and Small Set Screw (PN: 79-2003) with affected Lot Numbers 002, 003 and 004. Through the company’s manuf | 397 units | 2019-06-18 |
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.