Screw, Fixation, Bone
8MM X 30MM Cannulated Interference Screw With Guidewire
31manufacturers in China registered for this device type
16catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (15), Shanghai (5), Zhejiang (3). 19 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Sanbor Medical Xiamen, Inc. | Xiamen | Fujian | Contract manufacturer | 16 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
Showing 12 of 31. All 31 manufacturers in China registered for Screw, Fixation, Bone
Record
| Listed by | ConMed Corporation, United States |
|---|---|
| FDA product code | HWC |
| Device type | Screw, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K933352 |
| Record published | 2015-10-24 |
| Record revised | 2024-02-19 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Radiation Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature up to 104 °F; Storage environment temperature up to 40 °C; Special storage condition: KEEP DRY |
| Packaging | Box of 2 |
| Sizes | Length 14 to 114.3 mm; outer diameter 1.5 to 9 mm |
| Distribution end date | 2022-06-07 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| C8952 | Length 30 mm | In distribution | |
| C8950 | Length 20 mm | In distribution | |
| BXS6125 | Outer Diameter 1.5 mm | Withdrawn | |
| BXS6120 | Length 20 mm | Withdrawn | |
| BXS6118 | Outer Diameter 1.5 mm | Withdrawn | |
| BXS6220 | Outer Diameter 1.5 mm | 2 | Withdrawn |
| BXS6114 | Outer Diameter 1.5 mm | Withdrawn | |
| BXS6218 | Length 18 mm | 2 | Withdrawn |
| BXS6116 | Length 16 mm | Withdrawn | |
| 8974S | Length 40 mm | Withdrawn | |
| BXS6216 | Outer Diameter 1.5 mm | 2 | Withdrawn |
| BXS6000 | Outer Diameter 1.5 mm | 2 | Withdrawn |
| BXS6225 | Length 25 mm | 2 | Withdrawn |
| 8973S | Outer Diameter 7 mm | Withdrawn | |
| 8964S | Length 40 mm | Withdrawn | |
| 8963S | Length 35 mm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Screw, Fixation, Bone | Synthes Gmbh | 3,975 |
| Aptus | Medartis Inc. | 3,623 |
| Acumed | Acumed LLC | 3,187 |
| Arthrex® | Arthrex, Inc. | 2,781 |
| OsteoMed | Osteomed | 2,764 |
| Screw, Fixation, Bone | AAP Implantate AG | 2,176 |
| Screw, Fixation, Bone | Zimmer, Inc. | 1,993 |
| Arix System Bone Screw | Jeil Medical Corporation | 1,875 |
| Cannulated Screw System + | Tyber Medical | 1,814 |
| Cannulated Compression Headless Screw | Tyber Medical | 1,621 |
| Microware Bone Plates and Bone Screws | Microware Precision Co., Ltd. | 1,601 |
| Anthem | Globus Medical, Inc. | 1,538 |
Showing 12 of 5,775. All products under Screw, Fixation, Bone
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K182955 | 2019-01-22 |
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.