Bridalveil
Astura Medical’s BRIDALVEIL Offset Counter Torque is an accessory used with the BRIDALVEIL cervical spinal fixation system. It stabilizes the adjacent rod while a separate torque shaft…
Astura Medical’s BRIDALVEIL Offset Counter Torque is an accessory used with the BRIDALVEIL cervical spinal fixation system. It stabilizes the adjacent rod while a separate torque shaft tightens the rod-locking set screw. Its offset, high-top form provides clearance around the rod and screw assembly.
The listed model FZ3600003 is the directional perpendicular version. It is a manual instrument used alongside the system’s rod and locking components, not an implant left in the body.
Listed Item
Offset Counter Torque, High TOP, Directional, Perpendicular
Instrument Role
Astura lists counter-torque forms for different access directions. FZ3600003 is the perpendicular directional version.
4manufacturers in China registered for this device type
1,718catalogue numbers in this listing
1510(k) clearance
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 | Astura Medical, 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) | K171250 |
| Record published | 2021-07-21 |
| Record revised | 2025-12-10 (version 6) |
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 |
| Sizes | Width 2.4 to 20 mm; length 6 to 900 mm; outer diameter 3 to 9 mm; lumen/inner diameter 3.5 to 16 mm; angle 110 to 135 ° |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FAUA50048 | Width 5 mm | In distribution |
| FAFA50042 | Width 5 mm | In distribution |
| FDDA00020 | In distribution | |
| FAWA40042 | Width 4 mm | In distribution |
| FAYA45012 | Length 12 mm | In distribution |
| FCDB40605 | Width 4 mm | In distribution |
| FAMA50034 | Length 34 mm | In distribution |
| FCBB35050 | Width 3.5 mm | In distribution |
| FABA35016 | Width 3.5 mm | In distribution |
| FALA45034 | Length 34 mm | In distribution |
| FCBB35070 | Width 3.5 mm | In distribution |
| FAVA50026 | Width 5 mm | In distribution |
| FZ4300000 | In distribution | |
| FARA45040 | Length 40 mm | In distribution |
| FAMA45036 | Length 36 mm | In distribution |
| FAQA35030 | Length 30 mm | In distribution |
| FEGA60R11 | Width 6 mm | In distribution |
| FAKA35034 | Length 34 mm | In distribution |
| FABA35036 | Width 3.5 mm | In distribution |
| FAFA50012 | Width 5 mm | In distribution |
| FAUA50038 | Width 5 mm | In distribution |
| FAQA45018 | Length 18 mm | In distribution |
| FCDB35405 | Width 3.5 mm | In distribution |
| FATA50024 | Width 5 mm | In distribution |
| FZ3200000 | In distribution | |
| FZ3400000 | Outer Diameter 3.5 mm | In distribution |
| FACA35040 | Width 3.5 mm | In distribution |
| FANA40044 | Length 44 mm | In distribution |
| FAYA40014 | Length 14 mm | In distribution |
| FALA40044 | Length 44 mm | In distribution |
| FCAA40100 | Length 100 mm | In distribution |
| FABA35028 | Width 3.5 mm | In distribution |
| FAWA40026 | Width 4 mm | In distribution |
| FACA40048 | Width 4 mm | In distribution |
| FCBA35110 | Width 3.5 mm | In distribution |
| FADA40022 | Width 4 mm | In distribution |
| FA4A55040 | Length 40 mm | In distribution |
| FJAA45020 | Width 4.5 mm | In distribution |
| FAKA35032 | Length 32 mm | In distribution |
| FZ6000000 | In distribution | |
| FABA35034 | Width 3.5 mm | In distribution |
| FAJA50026 | Length 26 mm | In distribution |
| FAPA45026 | Length 26 mm | In distribution |
| FANA40038 | Length 38 mm | In distribution |
| FARA45042 | Length 42 mm | In distribution |
| FA2A35038 | Length 38 mm | In distribution |
| FCAA35400 | Length 400 mm | In distribution |
| FAEA50050 | Width 5 mm | In distribution |
| FAMA50050 | Length 50 mm | In distribution |
| FZ4500000 | In distribution | |
| FAYA45046 | Length 46 mm | In distribution |
| FEGA60L06 | Width 4 mm | In distribution |
| FZ3000000 | In distribution | |
| FZ9600000 | In distribution | |
| FAJA50024 | Length 24 mm | In distribution |
| FCAA35100 | Length 100 mm | In distribution |
| FAKA50040 | Width 5 mm | In distribution |
| FALA50040 | Length 40 mm | In distribution |
| FAWA40044 | Width 4 mm | In distribution |
| FAWA50030 | Length 30 mm | In distribution |
| FATA50040 | Width 5 mm | In distribution |
| FCBA40045 | Width 4 mm | In distribution |
| FZ1700000 | In distribution | |
| FA1A45040 | Length 40 mm | In distribution |
| FZ1500010 | In distribution | |
| FA2A45022 | Length 22 mm | In distribution |
| FAJA35032 | Length 32 mm | In distribution |
| FAKA45044 | Width 4.5 mm | In distribution |
| FZ6100000 | In distribution | |
| FAQA45026 | Length 26 mm | In distribution |
| FCBB35055 | Width 3.5 mm | In distribution |
| FAKA50012 | Width 5 mm | In distribution |
| FAMA35020 | Length 20 mm | In distribution |
| FECA04060 | Lumen/Inner Diameter 3.5 mm | In distribution |
| FAWA50008 | Length 8 mm | In distribution |
| FJAA52506 | Width 5.25 mm | In distribution |
| FCAA40360 | Length 360 mm | In distribution |
| FA4A55022 | Length 22 mm | In distribution |
| FA2A40026 | Length 26 mm | In distribution |
| FAYA35008 | Length 8 mm | In distribution |
| FA1A35020 | Length 20 mm | In distribution |
| FAYA40042 | Length 42 mm | In distribution |
| FABA40010 | Width 4 mm | In distribution |
| FJAA52520 | Width 5.25 mm | In distribution |
| FALA50032 | Length 32 mm | In distribution |
| FAVA50044 | Width 5 mm | In distribution |
| FAJA45050 | Length 50 mm | In distribution |
| FAMA40048 | Length 48 mm | In distribution |
| FCBA40100 | Width 4 mm | In distribution |
| FZ5300000 | In distribution | |
| FAYA40020 | Length 20 mm | In distribution |
| FZ8100000 | In distribution | |
| FZ1800001 | In distribution | |
| FAMA40032 | Length 32 mm | In distribution |
| FANA35040 | Length 40 mm | In distribution |
| FAVA50030 | Width 5 mm | In distribution |
| FABA45014 | Width 4.5 mm | In distribution |
| FAJA45026 | Length 26 mm | In distribution |
| FAYA45028 | Length 28 mm | In distribution |
| FA2A45034 | Length 34 mm | In distribution |
| FA3A55016 | Length 16 mm | In distribution |
| FA3A55040 | Length 40 mm | In distribution |
| FAJA45034 | Length 34 mm | In distribution |
| FCDA35409 | Width 3.5 mm | In distribution |
| FAJA50034 | Length 34 mm | In distribution |
| FAKA40042 | Width 4 mm | In distribution |
| FFAA00075 | Outer Diameter 7.5 mm | In distribution |
| FDAA00030 | In distribution | |
| FA2A45046 | Length 46 mm | In distribution |
| FCBA35020 | Width 3.5 mm | In distribution |
| FEFA03560 | Lumen/Inner Diameter 3.5 mm | In distribution |
| FAKA35008 | Length 8 mm | In distribution |
| FZ1100000 | In distribution | |
| FCAA40030 | Length 30 mm | In distribution |
| FJAA45009 | Width 4.5 mm | In distribution |
| FAMA35026 | Length 26 mm | In distribution |
| FALA50022 | Length 22 mm | In distribution |
| FALA45032 | Length 32 mm | In distribution |
| FZ2900000 | In distribution | |
| FADA45050 | Width 4.5 mm | In distribution |
| FALA50038 | Length 38 mm | In distribution |
| FCBA40035 | Width 4 mm | In distribution |
| FCBA40090 | Width 4 mm | In distribution |
| FAJA35022 | Width 3.5 mm | In distribution |
| FABA40026 | Width 4 mm | In distribution |
| FASA50024 | Width 5 mm | In distribution |
| FAWA35040 | Width 3.5 mm | In distribution |
| FAWA35038 | Width 3.5 mm | In distribution |
| FAMA40020 | Length 20 mm | In distribution |
| FAYA50046 | Length 46 mm | In distribution |
| FA2A40020 | Length 20 mm | In distribution |
| FANA40046 | Length 46 mm | In distribution |
| FAEA50022 | Width 5 mm | In distribution |
| FALA45040 | Length 40 mm | In distribution |
| FCBB40035 | Width 4 mm | In distribution |
| FAEA50038 | Width 5 mm | In distribution |
| FANA45036 | Length 36 mm | In distribution |
| FAPA45008 | Length 8 mm | In distribution |
| FARA35050 | Length 50 mm | In distribution |
| FAMA50030 | Length 30 mm | In distribution |
| FFAA00045 | Outer Diameter 4.5 mm | In distribution |
| FAPA45012 | Length 12 mm | In distribution |
| FAMA40034 | Length 34 mm | In distribution |
| FARA45032 | Length 32 mm | In distribution |
| FZ1200040 | Width 4 mm | In distribution |
| FALA50036 | Length 36 mm | In distribution |
| FAJA40018 | Length 18 mm | In distribution |
| FAQA40034 | Length 34 mm | In distribution |
| FAJA35012 | Width 3.5 mm | In distribution |
| FA2A40034 | Length 34 mm | In distribution |
| FCBB35020 | Width 3.5 mm | In distribution |
| FZ7200000 | In distribution | |
| FAKA45022 | Width 4.5 mm | In distribution |
| FA1A35024 | Length 24 mm | In distribution |
| FADA35040 | Width 3.5 mm | In distribution |
| FAYA45042 | Length 42 mm | In distribution |
| FCBA35045 | Width 3.5 mm | In distribution |
| FADA40024 | Width 4 mm | In distribution |
| FAWA50014 | Length 14 mm | In distribution |
| FA2A35024 | Length 24 mm | In distribution |
| FAYA40008 | Length 8 mm | In distribution |
| FAPA40026 | Length 26 mm | In distribution |
| FARA35024 | Length 24 mm | In distribution |
| FAKA40014 | Width 4 mm | In distribution |
| FAEA50030 | Width 5 mm | In distribution |
| FEGA40L04 | Length 120 mm | In distribution |
| FZ6300608 | Lumen/Inner Diameter 6 mm | In distribution |
| FAPA45020 | Length 20 mm | In distribution |
| FCCB35110 | Width 3.5 mm | In distribution |
| FEGA40R06 | Width 4 mm | In distribution |
| FAEA50018 | Width 5 mm | In distribution |
| FANA45050 | Length 50 mm | In distribution |
| FZ6600037 | Lumen/Inner Diameter 3.7 mm | In distribution |
| FALA45050 | Length 50 mm | In distribution |
| FATA50036 | Width 5 mm | In distribution |
| FASA50050 | Width 5 mm | In distribution |
| FZ7000000 | In distribution | |
| FAFA50014 | Width 5 mm | In distribution |
| FAYA40038 | Length 38 mm | In distribution |
| FA1A45026 | Length 26 mm | In distribution |
| FAQA40042 | Length 42 mm | In distribution |
| FAMA45046 | Length 46 mm | In distribution |
| FAPA35014 | Length 14 mm | In distribution |
| FADA40048 | Width 4 mm | In distribution |
| FAHA50036 | Width 5 mm | In distribution |
| FANA35034 | Length 34 mm | In distribution |
| FARA35034 | Length 34 mm | In distribution |
| FCAB35035 | Length 35 mm | In distribution |
| FJAA52515 | Width 5.25 mm | In distribution |
| FCBB40045 | Width 4 mm | In distribution |
| FCAB35020 | Length 20 mm | In distribution |
| FA3A55048 | Length 48 mm | In distribution |
| FAWA50020 | Length 20 mm | In distribution |
| FARA40048 | Length 48 mm | In distribution |
| FAVA50036 | Width 5 mm | In distribution |
| FAJA35048 | Length 48 mm | In distribution |
| FCBA35035 | Width 3.5 mm | In distribution |
| FAJA50018 | Length 18 mm | In distribution |
| FACA45020 | Width 4.5 mm | In distribution |
| FADA40026 | Width 4 mm | In distribution |
| FAPA40016 | Length 16 mm | In distribution |
| FACA40034 | Width 4 mm | In distribution |
| FABA45010 | Width 4.5 mm | In distribution |
| FADA40018 | Width 4 mm | In distribution |
| FAYA50010 | Length 10 mm | In distribution |
| FAWA50034 | Length 34 mm | In distribution |
| FACA40050 | Width 4 mm | In distribution |
| FANA35018 | Length 18 mm | In distribution |
| FABA40014 | Width 4 mm | In distribution |
| FAUA50032 | Width 5 mm | In distribution |
| FAPA40044 | Length 44 mm | In distribution |
| FABA40012 | Width 4 mm | In distribution |
| FAFA50030 | Width 5 mm | In distribution |
| FAYA45010 | Length 10 mm | In distribution |
| FCDA40635 | Width 4 mm | In distribution |
| FCCA40110 | Width 4 mm | In distribution |
| FAHA50024 | Width 5 mm | In distribution |
| FAKA40032 | Width 4 mm | In distribution |
| FA3A55034 | Length 34 mm | In distribution |
| FARA40040 | Length 40 mm | In distribution |
| FAMA50042 | Length 42 mm | In distribution |
| FANA40036 | Length 36 mm | In distribution |
| FEGA40R10 | Width 6 mm | In distribution |
| FA3A55010 | Length 10 mm | In distribution |
| FA1A35044 | Length 44 mm | In distribution |
| FARA40038 | Length 38 mm | In distribution |
| FZ3600003 | In distribution | |
| FABA35042 | Width 3.5 mm | In distribution |
| FA2A50024 | Length 24 mm | In distribution |
| FELA00000 | In distribution | |
| FZ6800525 | Width 5.25 mm | In distribution |
| FAMA40030 | Length 30 mm | In distribution |
| FJAA45014 | Width 4.5 mm | In distribution |
| FATA50008 | Width 5 mm | In distribution |
| FAKA35020 | Length 20 mm | In distribution |
| FZ1200130 | Width 3 mm | In distribution |
| FAJA50020 | Length 20 mm | In distribution |
| FJAA45024 | Width 4.5 mm | In distribution |
| FAPA35048 | Length 48 mm | In distribution |
| FZ1900050 | In distribution | |
| FADA35046 | Width 3.5 mm | In distribution |
| FASA50018 | Width 5 mm | In distribution |
| FAJA40034 | Length 34 mm | In distribution |
| FAJA50012 | Length 12 mm | In distribution |
| FA1A45022 | Length 22 mm | In distribution |
| FADA45038 | Width 4.5 mm | In distribution |
| FCBA35100 | Width 3.5 mm | In distribution |
| FATA50038 | Width 5 mm | In distribution |
| FZ2700000 | Outer Diameter 3.5 mm | In distribution |
| FAKA35016 | Length 16 mm | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| Perla ® | Spineart SA | 349 |
Showing 12 of 336. All products under Posterior Cervical Screw System
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K171250 | 2017-10-02 |
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.