I.co.s
The I.CO.S Screw is a cannulated compression screw with non-threaded shaft, allowing optimal compression. The head of this screw can be screwed and translated along the body in order to…
The I.CO.S Screw is a cannulated compression screw with non-threaded shaft, allowing optimal compression. The head of this screw can be screwed and translated along the body in order to increase the compression controlled by the surgeon. It also has a self-tapping screw tip. The I.CO.S screw is indicated for fixing the elective osteotomies of the forefoot and/or mid foot bones and for fractures fixation. This set includes I.CO.S screws that are 6mm in diameter. Instruments are also provided.
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 | Newdeal Sas, United States |
|---|---|
| FDA product code | HWC |
| Device type | Screw, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Record published | 2017-10-09 |
| Record revised | 2025-04-28 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Special storage condition: Store in dry place. |
| Distribution end date | 2025-04-28 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 105438ND | 4.0mm diam. x 38mm length | Withdrawn |
| 105450ND | 4.0mm diam. x 50mm length | Withdrawn |
| 105434ND | 4.0mm diam. x 34mm length | Withdrawn |
| 105665ND | 6.5mm diam. x 65mm length | Withdrawn |
| ICOS6INSTSET | Withdrawn | |
| 105455ND | 4.0mm diam. x 55mm length | Withdrawn |
| ICOS4INSTSET | Withdrawn | |
| 105670ND | 6.5mm diam. x 70mm length | Withdrawn |
| 105436ND | 4.0mm diam. x 36mm length | Withdrawn |
| 105440ND | 4.0mm diam. x 40mm length | Withdrawn |
| 105645ND | 6.5mm diam. x 45mm length | Withdrawn |
| 105660ND | 6.5mm diam. x 60mm length | Withdrawn |
| 105428ND | 4.0mm diam. x 28mm length | Withdrawn |
| 105685ND | 6.5mm diam. x 85mm length | Withdrawn |
| 105445ND | 4.0mm diam. x 45mm length | Withdrawn |
| 105680ND | 6.5mm diam. x 80mm length | Withdrawn |
| 105640ND | 6.5mm diam. x 40mm length | Withdrawn |
| 105675ND | 6.5mm diam. x 75mm length | Withdrawn |
| 105432ND | 4.0mm diam. x 32mm length | Withdrawn |
| 105655ND | 6.5mm diam. x 55mm length | Withdrawn |
| 105430ND | 4.0mm diam. x 30mm length | Withdrawn |
| 105426ND | 4.0mm diam. x 26mm length | Withdrawn |
| 105650ND | 6.5mm diam. x 50mm length | Withdrawn |
| 105690ND | 6.5mm diam. x 90mm length | Withdrawn |
| 105460ND | 4.0mm diam. x 60mm length | 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 |
|---|---|
| K071639 | 2007-07-09 |
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.