Bridalveil
Polyaxial Screw #1
7manufacturers in China registered for this device type
58catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (4), Shandong (2), Shanghai (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| 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 |
Record
| Listed by | Astura Medical, United States |
|---|---|
| FDA product code | OSH |
| Device type | Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2021-07-16 |
| Record revised | 2025-12-10 (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 |
| Sizes | Length 3.5 to 40 mm; outer diameter 8 to 50 mm; width 4.5 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FAAA35020 | Length 3.5 mm | In distribution |
| FAAA40030 | Length 4 mm | In distribution |
| FAAA35036 | Length 3.5 mm | In distribution |
| FAAA40048 | Length 4 mm | In distribution |
| FAAA35040 | Length 3.5 mm | In distribution |
| FAAA45016 | Width 4.5 mm | In distribution |
| FAAA40024 | Length 4 mm | In distribution |
| FAAA40036 | Length 4 mm | In distribution |
| FAAA35034 | Length 3.5 mm | In distribution |
| FAAA45008 | Width 4.5 mm | In distribution |
| FAAA45036 | Width 4.5 mm | In distribution |
| FAAA40016 | Length 4 mm | In distribution |
| FAAA35018 | Length 3.5 mm | In distribution |
| FAAA45014 | Width 4.5 mm | In distribution |
| FAAA35022 | Length 3.5 mm | In distribution |
| FAAA35016 | Length 3.5 mm | In distribution |
| FAAA45034 | Width 4.5 mm | In distribution |
| FAAA35038 | Length 3.5 mm | In distribution |
| FAAA40044 | Length 4 mm | In distribution |
| FAAA40042 | Length 4 mm | In distribution |
| FAAA40050 | Length 4 mm | In distribution |
| FAAA45030 | Width 4.5 mm | In distribution |
| FAAA40020 | Length 4 mm | In distribution |
| FAAA35028 | Length 3.5 mm | In distribution |
| FAAA35030 | Length 3.5 mm | In distribution |
| FAAA40040 | Length 4 mm | In distribution |
| FAAA40038 | Length 4 mm | In distribution |
| FAAA45018 | Width 4.5 mm | In distribution |
| FAAA40018 | Length 4 mm | In distribution |
| FAAA40026 | Length 4 mm | In distribution |
| FAAA40022 | Length 4 mm | In distribution |
| FAAA40028 | Length 4 mm | In distribution |
| FAAA45022 | Width 4.5 mm | In distribution |
| FAAA35044 | Length 3.5 mm | In distribution |
| FAAA40012 | Length 4 mm | In distribution |
| FAAA45024 | Width 4.5 mm | In distribution |
| FAAA45020 | Width 4.5 mm | In distribution |
| FAAA45038 | Width 4.5 mm | In distribution |
| FAAA45040 | Width 4.5 mm | In distribution |
| FAAA45012 | Width 4.5 mm | In distribution |
| FAAA35026 | Length 3.5 mm | In distribution |
| FAAA40008 | Length 4 mm | In distribution |
| FAAA45032 | Width 4.5 mm | In distribution |
| FAAA35042 | Length 3.5 mm | In distribution |
| FAAA40046 | Length 4 mm | In distribution |
| FAAA40034 | Length 4 mm | In distribution |
| FAAA40032 | Length 4 mm | In distribution |
| FAAA35050 | Length 3.5 mm | In distribution |
| FAAA35032 | Length 3.5 mm | In distribution |
| FAAA45026 | Width 4.5 mm | In distribution |
| FAAA35014 | Length 3.5 mm | In distribution |
| FAAA35046 | Length 3.5 mm | In distribution |
| FAAA35048 | Length 3.5 mm | In distribution |
| FAAA45028 | Width 4.5 mm | In distribution |
| FAAA35024 | Length 3.5 mm | In distribution |
| FAAA40010 | Length 4 mm | In distribution |
| FAAA40014 | Length 4 mm | In distribution |
| FAAA45010 | Width 4.5 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Creo | Globus Medical, Inc. | 1,821 |
| ReLine | Nuvasive, Inc. | 1,093 |
| Olympic | Astura Medical | 951 |
| Nex-D2 | Next Orthosurgical | 887 |
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 876 |
| Arsenal | Alphatec Spine, Inc. | 820 |
| Apex-DL Spine System | Spinecraft LLC | 691 |
| Polaris™ 4.75 Spinal System | Biomet Spine | 413 |
| Expedium | Medos International Sàrl | 400 |
| Implanet Spine System | Implanet | 386 |
| Everest® Spinal System | VB Spine LLC | 299 |
| Arsenal Deformity Spinal Fixation System | Alphatec Spine, Inc. | 258 |
Showing 12 of 73. All products under Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K153446 | 2016-04-08 |
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.