Biolign Rotoloc
Roto-Loc Variable Angled Cervical Screw 4.2 x 16mm
14manufacturers in China registered for this device type
68catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (5), Shanghai (3), Zhejiang (2). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| 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 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| 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 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
Showing 12 of 14. All 14 manufacturers in China registered for Appliance, Fixation, Spinal Intervertebral Body
Record
| Listed by | Elite Surgical Supplies (PTY) Ltd, South Africa |
|---|---|
| FDA product code | KWQ |
| Device type | Appliance, Fixation, Spinal Intervertebral Body |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| Establishment | Contract manufacturer, Complaint-file establishment, Manufacturer |
| 510(k) | K200523 |
| Record published | 2021-07-16 |
| Record revised | 2025-11-20 (version 3) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Sizes | Length 12 to 94 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| RL200623 | Length 62 mm | In distribution |
| RLSS4216 | Length 16 mm | In distribution |
| RL200663 | Length 66 mm | In distribution |
| RLSS4212 | Length 12 mm | In distribution |
| RL200342 | Length 34 mm | In distribution |
| RLFS4616 | Length 16 mm | In distribution |
| RL200724 | Length 72 mm | In distribution |
| RL200543 | Length 54 mm | In distribution |
| RL200483 | Length 48 mm | In distribution |
| RL200382 | Length 38 mm | In distribution |
| RL200422 | Length 42 mm | In distribution |
| RLSS4214 | Length 14 mm | In distribution |
| RL200261 | Length 26 mm | In distribution |
| RL200664 | Length 66 mm | In distribution |
| RLSS4614 | Length 14 mm | In distribution |
| RLFS4214 | Length 14 mm | In distribution |
| RL200644 | Length 64 mm | In distribution |
| RL200462 | Length 46 mm | In distribution |
| RL200502 | Length 50 mm | In distribution |
| RL200683 | Length 68 mm | In distribution |
| RL200522 | Length 52 mm | In distribution |
| RL200784 | Length 78 mm | In distribution |
| RL200361 | Length 36 mm | In distribution |
| RL200341 | Length 34 mm | In distribution |
| RLFS4614 | Length 14 mm | In distribution |
| RL200583 | Length 58 mm | In distribution |
| RL200804 | Length 80 mm | In distribution |
| RL200201 | Length 20 mm | In distribution |
| RL200704 | Length 70 mm | In distribution |
| RLFS4612 | Length 12 mm | In distribution |
| RLFS4216 | Length 16 mm | In distribution |
| RL200703 | Length 70 mm | In distribution |
| RL200844 | Length 84 mm | In distribution |
| RL200442 | Length 44 mm | In distribution |
| RL200884 | Length 88 mm | In distribution |
| RL200824 | Length 82 mm | In distribution |
| RL200542 | Length 54 mm | In distribution |
| RL200503 | Length 50 mm | In distribution |
| RL200221 | Length 22 mm | In distribution |
| RL200744 | Length 74 mm | In distribution |
| RL200322 | Length 32 mm | In distribution |
| RL200723 | Length 72 mm | In distribution |
| RL200743 | Length 74 mm | In distribution |
| RLSS4612 | Length 12 mm | In distribution |
| RLSS4218 | Length 18 mm | In distribution |
| RL200523 | Length 52 mm | In distribution |
| RL200241 | Length 24 mm | In distribution |
| RLFS4212 | Length 12 mm | In distribution |
| RL200624 | Length 62 mm | In distribution |
| RL200301 | Length 30 mm | In distribution |
| RL200281 | Length 28 mm | In distribution |
| RL200904 | Length 90 mm | In distribution |
| RL200924 | Length 92 mm | In distribution |
| RL200482 | Length 48 mm | In distribution |
| RLSS4616 | Length 16 mm | In distribution |
| RL200603 | Length 58 mm | In distribution |
| RL200944 | Length 94 mm | In distribution |
| RL200362 | Length 36 mm | In distribution |
| RL200321 | Length 32 mm | In distribution |
| RL200764 | Length 76 mm | In distribution |
| RLSS4618 | Length 18 mm | In distribution |
| RL200563 | Length 56 mm | In distribution |
| RLFS4618 | Length 18 mm | In distribution |
| RLFS4218 | Length 18 mm | In distribution |
| RL200684 | Length 68 mm | In distribution |
| RL200643 | Length 64 mm | In distribution |
| RL200402 | Length 40 mm | In distribution |
| RL200864 | Length 86 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ReLine | Nuvasive, Inc. | 2,998 |
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 2,568 |
| Creo | Globus Medical, Inc. | 1,765 |
| AccelFix Spinal Fixation System | L&K Biomed Co., Ltd. | 1,755 |
| Ozark Cervical Plate System | VB Spine LLC | 1,460 |
| Sirion | Astura Medical | 1,246 |
| Apex Spine System | Spinecraft LLC | 1,187 |
| AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 986 |
| Astra Spine System | Spinecraft LLC | 970 |
| Zavation | Zavation | 966 |
| ACP | Nuvasive, Inc. | 918 |
| Polaris™ 5.5 Spinal System | Biomet Spine | 877 |
Showing 12 of 855. All products under Appliance, Fixation, Spinal Intervertebral Body
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K200523 | 2020-04-30 |
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.