Envision
4.35 mm x 12 mm Screw Self-Drilling
14manufacturers in China registered for this device type
46catalogue 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 | Ortho Development Corp., United States |
|---|---|
| FDA product code | KWQ |
| Device type | Appliance, Fixation, Spinal Intervertebral Body |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2015-08-31 |
| Record revised | 2025-11-20 (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, manufacturing date |
| Sizes | Length 12 to 95 mm; outer diameter 4 to 4.35 mm |
| Distribution end date | 2016-09-24 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 154-6012 | Length 12 mm | Withdrawn |
| 154-6243 | Outer Diameter 4.35 mm | Withdrawn |
| 154-5120 | Length 20 mm | Withdrawn |
| 154-6843 | Length 18 mm | Withdrawn |
| 154-6014 | Outer Diameter 4 mm | Withdrawn |
| 154-5465 | Length 65 mm | Withdrawn |
| 154-6443 | Outer Diameter 4.35 mm | Withdrawn |
| 154-5358 | Length 58 mm | Withdrawn |
| 154-5475 | Length 75 mm | Withdrawn |
| 154-6643 | Outer Diameter 4.35 mm | Withdrawn |
| 154-6016 | Outer Diameter 4 mm | Withdrawn |
| 154-6312 | Length 12 mm | Withdrawn |
| 154-6440 | Length 14 mm | Withdrawn |
| 154-1000 | Withdrawn | |
| 154-5361 | Length 61 mm | Withdrawn |
| 154-5228 | Length 28 mm | Withdrawn |
| 154-6840 | Outer Diameter 4 mm | Withdrawn |
| 154-5367 | Length 67 mm | Withdrawn |
| 154-5470 | Length 70 mm | Withdrawn |
| 154-5460 | Length 60 mm | Withdrawn |
| 154-5364 | Length 64 mm | Withdrawn |
| 154-6240 | Length 12 mm | Withdrawn |
| 154-5232 | Length 32 mm | Withdrawn |
| 154-5235 | Length 35 mm | Withdrawn |
| 154-5238 | Length 38 mm | Withdrawn |
| 154-5230 | Length 30 mm | Withdrawn |
| 154-5346 | Length 46 mm | Withdrawn |
| 154-5247 | Length 47 mm | Withdrawn |
| 154-5118 | Length 18 mm | Withdrawn |
| 154-5226 | Length 26 mm | Withdrawn |
| 154-5490 | Length 90 mm | Withdrawn |
| 154-5244 | Length 44 mm | Withdrawn |
| 154-5355 | Length 55 mm | Withdrawn |
| 154-6316 | Outer Diameter 4.35 mm | Withdrawn |
| 154-5122 | Length 22 mm | Withdrawn |
| 154-5480 | Length 80 mm | Withdrawn |
| 154-5124 | Length 24 mm | Withdrawn |
| 154-6314 | Outer Diameter 4.35 mm | Withdrawn |
| 154-6640 | Outer Diameter 4 mm | Withdrawn |
| 154-5241 | Length 41 mm | Withdrawn |
| 154-5116 | Length 16 mm | Withdrawn |
| 154-5349 | Length 49 mm | Withdrawn |
| 154-5485 | Length 85 mm | Withdrawn |
| 154-5352 | Length 52 mm | Withdrawn |
| 154-5114 | Length 14 mm | Withdrawn |
| 154-5495 | Length 95 mm | Withdrawn |
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 |
|---|---|
| K020649 | 2002-04-05 |
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.