Firebird SFS
8.5MM X 55MM HA Coated Bone Screw Self-Tapping, Cannulated, Sterile
15manufacturers in China registered for this device type
299catalogue numbers in this listing
6recalls on this code
Who Else Makes It
Concentrated in Jiangsu (6), Shanghai (3), Shandong (3). 6 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 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| 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 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
| Shanghai Reach Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 30 |
| Changzhou Geasure Medical Apparatus AND Instruments Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 25 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
Showing 12 of 15. All 15 manufacturers in China registered for Thoracolumbosacral Pedicle Screw System
Record
| Listed by | Orthofix US LLC, United States |
|---|---|
| FDA product code | NKB |
| Device type | Thoracolumbosacral Pedicle Screw System |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K122901 |
| Record published | 2016-03-14 |
| Record revised | 2026-02-20 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
| Sizes | Outer diameter 4.5 to 11.5 mm; length 40 to 110 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 77-8045 | Outer Diameter 10.5 mm | In distribution |
| 44-3935 | In distribution | |
| 77-8975 | In distribution | |
| 77-7510 | In distribution | |
| 77-8970 | Length 70 mm | In distribution |
| 44-3065 | In distribution | |
| 77-5725SP | In distribution | |
| 44-3565 | In distribution | |
| 77-8980 | Outer Diameter 4.5 mm | In distribution |
| 44-3965 | In distribution | |
| 44-3710 | In distribution | |
| 77-8930 | In distribution | |
| 44-3890 | In distribution | |
| 44-3655 | In distribution | |
| 44-3690 | In distribution | |
| 77-5555SP | In distribution | |
| 44-3830 | In distribution | |
| 77-8130 | In distribution | |
| 77-5855SP | In distribution | |
| 77-7810 | In distribution | |
| 77-5825SP | In distribution | |
| 77-8170 | Length 70 mm | In distribution |
| 44-3055 | In distribution | |
| 77-8160 | Outer Diameter 11.5 mm | In distribution |
| 44-3050 | In distribution | |
| 44-3670 | In distribution | |
| 77-7640 | In distribution | |
| 44-3810 | In distribution | |
| 44-3945 | In distribution | |
| 77-8840 | In distribution | |
| 51-8072 | In distribution | |
| 77-7830 | In distribution | |
| 44-3790 | In distribution | |
| 77-5845SP | In distribution | |
| 44-3975 | In distribution | |
| 44-3395 | In distribution | |
| 44-3185 | In distribution | |
| 77-8965 | In distribution | |
| 44-3160 | In distribution | |
| 44-3835 | In distribution | |
| 44-3980 | In distribution | |
| 44-3650 | In distribution | |
| 77-7565 | In distribution | |
| 77-8885 | In distribution | |
| 44-3775 | In distribution | |
| 77-8070 | Outer Diameter 10.5 mm | In distribution |
| 77-8040 | Length 40 mm | In distribution |
| 44-3525 | In distribution | |
| 77-5550SP | In distribution | |
| 44-3550 | In distribution | |
| 77-8145 | Outer Diameter 11.5 mm | In distribution |
| 77-7570 | In distribution | |
| 77-8110 | Length 100 mm | In distribution |
| 77-8925 | In distribution | |
| 77-5630SP | In distribution | |
| 44-3930 | In distribution | |
| 44-3390 | In distribution | |
| 77-8195 | In distribution | |
| 77-7590 | In distribution | |
| 44-3595 | In distribution | |
| 77-8940 | Outer Diameter 4.5 mm | In distribution |
| 44-3765 | In distribution | |
| 77-8895 | In distribution | |
| 44-3630 | In distribution | |
| 44-3870 | In distribution | |
| 44-3865 | In distribution | |
| 77-8860 | In distribution | |
| 77-7811 | In distribution | |
| 44-3995 | In distribution | |
| 77-7885 | In distribution | |
| 77-7535 | In distribution | |
| 77-7755 | In distribution | |
| 77-5645SP | In distribution | |
| 77-7660 | In distribution | |
| 77-7865 | In distribution | |
| 44-3145 | In distribution | |
| 77-8175 | In distribution | |
| 77-8150 | Length 50 mm | In distribution |
| 77-7850 | In distribution | |
| 77-8011 | Outer Diameter 10.5 mm | In distribution |
| 44-3010 | In distribution | |
| 44-3635 | In distribution | |
| 77-8910 | Outer Diameter 4.5 mm | In distribution |
| 44-3950 | In distribution | |
| 44-3555 | In distribution | |
| 44-3560 | In distribution | |
| 77-8135 | In distribution | |
| 44-3575 | In distribution | |
| 77-8060 | Length 60 mm | In distribution |
| 77-8875 | In distribution | |
| 77-5525SP | In distribution | |
| 77-8111 | Outer Diameter 11.5 mm | In distribution |
| 77-8890 | In distribution | |
| 44-3680 | In distribution | |
| 77-5735SP | In distribution | |
| 77-5635SP | In distribution | |
| 77-5740SP | In distribution | |
| 77-5755SP | In distribution | |
| 44-3855 | In distribution | |
| 44-3730 | In distribution | |
| 77-7845 | In distribution | |
| 77-8960 | Outer Diameter 4.5 mm | In distribution |
| 77-5650SP | In distribution | |
| 44-3111 | In distribution | |
| 77-8985 | In distribution | |
| 44-3760 | In distribution | |
| 44-3940 | In distribution | |
| 77-5655SP | In distribution | |
| 77-7735 | In distribution | |
| 44-3825 | In distribution | |
| 44-3075 | In distribution | |
| 51-8081 | In distribution | |
| 77-7685 | In distribution | |
| 77-7880 | In distribution | |
| 44-3540 | In distribution | |
| 77-8055 | Outer Diameter 10.5 mm | In distribution |
| 77-8880 | In distribution | |
| 51-8032 | In distribution | |
| 77-7680 | In distribution | |
| 77-7740 | In distribution | |
| 77-7550 | In distribution | |
| 44-3711 | In distribution | |
| 77-8810 | In distribution | |
| 44-3030 | In distribution | |
| 44-3190 | In distribution | |
| 51-8091 | In distribution | |
| 77-8085 | In distribution | |
| 44-3925 | In distribution | |
| 77-7610 | In distribution | |
| 77-7675 | In distribution | |
| 44-3195 | In distribution | |
| 77-7780 | In distribution | |
| 77-7895 | In distribution | |
| 77-8835 | In distribution | |
| 44-3780 | In distribution | |
| 44-3745 | In distribution | |
| 77-7855 | In distribution | |
| 44-3740 | In distribution | |
| 77-7655 | In distribution | |
| 44-3811 | In distribution | |
| 44-3960 | In distribution | |
| 51-8031 | In distribution | |
| 77-7750 | In distribution | |
| 77-7860 | In distribution | |
| 77-7840 | In distribution | |
| 77-7875 | In distribution | |
| 44-3011 | In distribution | |
| 77-8911 | Length 100 mm | In distribution |
| 77-8845 | In distribution | |
| 44-3845 | In distribution | |
| 77-7560 | In distribution | |
| 77-5530SP | In distribution | |
| 77-7770 | In distribution | |
| 44-3770 | In distribution | |
| 77-7725 | In distribution | |
| 77-5840SP | In distribution | |
| 77-8165 | In distribution | |
| 77-7690 | In distribution | |
| 77-7835 | In distribution | |
| 77-8950 | Outer Diameter 4.5 mm | In distribution |
| 77-7670 | In distribution | |
| 44-3130 | In distribution | |
| 44-3750 | In distribution | |
| 44-3685 | In distribution | |
| 77-8140 | Length 40 mm | In distribution |
| 77-7530 | In distribution | |
| 77-8155 | Outer Diameter 11.5 mm | In distribution |
| 44-3640 | In distribution | |
| 77-8850 | In distribution | |
| 77-7790 | In distribution | |
| 77-8180 | Outer Diameter 11.5 mm | In distribution |
| 77-8811 | In distribution | |
| 44-3080 | In distribution | |
| 77-8865 | In distribution | |
| 44-3785 | In distribution | |
| 77-7765 | In distribution | |
| 77-7890 | In distribution | |
| 77-7645 | In distribution | |
| 77-7785 | In distribution | |
| 44-3095 | In distribution | |
| 77-8065 | In distribution | |
| 44-3155 | In distribution | |
| 77-7540 | In distribution | |
| 77-8190 | Length 90 mm | In distribution |
| 77-5730SP | In distribution | |
| 77-7665 | In distribution | |
| 44-3580 | In distribution | |
| 77-7745 | In distribution | |
| 44-3165 | In distribution | |
| 44-3125 | In distribution | |
| 44-3611 | In distribution | |
| 44-3840 | In distribution | |
| 44-3885 | In distribution | |
| 44-3665 | In distribution | |
| 77-7580 | In distribution | |
| 77-7555 | In distribution | |
| 77-7511 | In distribution | |
| 77-8125 | In distribution | |
| 44-3675 | In distribution | |
| 44-3070 | In distribution | |
| 77-7611 | In distribution | |
| 77-8080 | Length 80 mm | In distribution |
| 77-7545 | In distribution | |
| 77-8090 | Outer Diameter 10.5 mm | In distribution |
| 77-7795 | In distribution | |
| 77-8030 | In distribution | |
| 44-3060 | In distribution | |
| 77-7595 | In distribution | |
| 44-3170 | In distribution | |
| 77-7711 | In distribution | |
| 77-8025 | In distribution | |
| 77-7710 | In distribution | |
| 77-5750SP | In distribution | |
| 52-6045 | In distribution | |
| 77-7695 | In distribution | |
| 44-3140 | In distribution | |
| 44-3910 | In distribution | |
| 44-3860 | In distribution | |
| 44-3735 | In distribution | |
| 77-7650 | In distribution | |
| 51-8041 | In distribution | |
| 44-3895 | In distribution | |
| 77-8945 | Length 45 mm | In distribution |
| 77-8010 | Outer Diameter 10.5 mm | In distribution |
| 51-8042 | In distribution | |
| 44-3040 | In distribution | |
| 77-7870 | In distribution | |
| 44-3880 | In distribution | |
| 44-3795 | In distribution | |
| 77-7585 | In distribution | |
| 44-3085 | In distribution | |
| 77-7525 | In distribution | |
| 51-8030 | In distribution | |
| 77-7630 | In distribution | |
| 44-3695 | In distribution | |
| 77-7625 | In distribution | |
| 77-8185 | In distribution | |
| 77-8050 | Length 50 mm | In distribution |
| 44-3850 | In distribution | |
| 44-3045 | In distribution | |
| 77-5640SP | In distribution | |
| 77-7775 | In distribution | |
| 44-3110 | In distribution | |
| 77-5545SP | In distribution | |
| 44-3955 | In distribution | |
| 77-7825 | In distribution | |
| 77-8870 | In distribution | |
| 44-3585 | In distribution | |
| 77-8075 | In distribution | |
| 77-8935 | In distribution |
Showing 250 of 299 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| The Jasper Spinal Fixation System | Gbs Commonwealth Co., Ltd. | 32,491 |
| Invictus | Alphatec Spine, Inc. | 4,722 |
| Vital Spinal Fixation System | Highridge Medical, LLC | 4,422 |
| Innoverse Spinal System | CG MedTech Co., Ltd. | 4,240 |
| 4CIS® Chiron Spinal Fixation System | Alpha AI Co., Ltd. | 3,787 |
| LnK Spinal Fixation System | L&K Biomed Co., Ltd. | 3,522 |
| Hedjet System | Medyssey Co., Ltd. | 3,438 |
| Anax™ 5.5 Spinal System | CG MedTech Co., Ltd. | 3,424 |
| Mega Plus MIS Spine System | BK Meditech Co., Ltd. | 3,396 |
| ReLine | Nuvasive, Inc. | 2,882 |
| Nex-D2 | Next Orthosurgical | 2,765 |
| AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 2,386 |
Showing 12 of 1,490. All products under Thoracolumbosacral Pedicle Screw System
Recalls
3 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 |
|---|---|---|---|---|---|
| 2025-09-19 | Class II | Process change control | Polyaxial screws do not meet performance standards. | 624 units | |
| 2017-08-02 | Class II | Nonconforming Material/Component | The plastic core of the Decorticating Planer was found to be missing, which could result in scoring of the bone screw neck if used at or beyond a 23 degree angle. | 6 planers | 2018-05-04 |
| 2015-05-18 | Class II | Unknown/Undetermined by firm | The Firebird Spinal Fixation System 6.5 mm x 55 mm Bone Screw, Self-Tapping is currently mislabeled at the distal tip of the bone screw showing a length measurement of 50 mm instead of 55 mm. | 45 units | 2015-10-30 |
| 2011-04-01 | Not classified | Device Design | Upon reaching torque limit, there is a possibility the product may jam or exhibit a ratchet direction switch from forward to reverse. | 287 units | 2012-03-23 |
| 2010-10-22 | Not classified | Other | There is a possibility that certain Anti-Splay Caps may not mate properly during assembly of the construct to the Screw Body with Multi-Axial Reduction Screw Assemblies. | 166 Units | 2011-04-25 |
| 2010-10-22 | Not classified | Other | There is a possibility that certain Multi-Axial Screws have spherical heads measuring less than the allowable tolerance. | 27 (19 of 77-7630) (8 of 77-8630) | 2011-05-31 |
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.