RetroFix
Cannulated Tapered Screw Overall Length 110MM Proximal Diameter 5.5MM Proximal Lenght 25MM Distal Diameter 4.5MM Material: TI
31manufacturers in China registered for this device type
76catalogue 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 | Retrofix Screws, LLC, United States |
|---|---|
| FDA product code | HWC |
| Device type | Screw, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K200226 |
| Record published | 2020-12-23 |
| Record revised | 2024-02-19 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, manufacturing date |
| Sizes | Length 80 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 80L:PROX5-35L:DIST4 TI | In distribution | |
| 90L:PROX6-25L:DIST4 TI | In distribution | |
| 90L:PROX6-40L:DIST4 TI | In distribution | |
| 80L:PROX5-30L:DIST4 TI | In distribution | |
| 80L:PROX6-40L:DIST4.5 TI | In distribution | |
| Tray, Ankle surgical procedure | In distribution | |
| K-Wire, 1.3mm x 225mm PK 1 | In distribution | |
| Drill Guide | In distribution | |
| K-Wire, 1.3mm x 300mm PK 25 | In distribution | |
| 110L:PROX6-25L:DIST4.5 TI | In distribution | |
| 110L:PROX6-35L:DIST4 TI | In distribution | |
| 80L:PROX5.5-25L:DIST4.5 TI | In distribution | |
| 80L:PROX5.5-35L:DIST4 TI | In distribution | |
| 80L:PROX5-25L:DIST4 TI | In distribution | |
| 90L:PROX5.5-25L:DIST4.5 TI | In distribution | |
| 90L:PROX5.5-25L:DIST4 TI | In distribution | |
| 90L:PROX6-40L:DIST4.5 TI | In distribution | |
| K-Wire, 1.3mm x 300mm PK 1 | In distribution | |
| 110L:PROX5.5-30L:DIST4 TI | In distribution | |
| Drill, 4.7mm x 180mm, cannulated | In distribution | |
| 80L:PROX5.5-30L:DIST4.5 TI | In distribution | |
| 90L:PROX5-40L:DIST4.5 TI | In distribution | |
| 90L:PROX5.5-30L:DIST4.5 TI | In distribution | |
| 110L:PROX6-40L:DIST4 TI | In distribution | |
| 100L:PROX6-30L:DIST4.5 TI | In distribution | |
| 80L:PROX5-25L:DIST4.5 TI | In distribution | |
| 90L:PROX5.5-40L:DIST4 TI | In distribution | |
| 110L:PROX5.5-30L:DIST4.5 TI | In distribution | |
| Tray, lid for surgical tray | In distribution | |
| Drill, 4mm x 180mm, cannulated | In distribution | |
| 80L:PROX6-35L:DIST4.5 TI | In distribution | |
| 80L:PROX6-30L:DIST4 TI | In distribution | |
| 100L:PROX6-40L:DIST4.5 TI | In distribution | |
| 80L:PROX5-35L:DIST4.5 TI | In distribution | |
| tray, upper instrument drawer | In distribution | |
| 100L:PROX5-30L:DIST4 TI | In distribution | |
| 90L:PROX5.5-30L:DIST4 TI | In distribution | |
| 80L:PROX6-35L:DIST4 TI | In distribution | |
| 80L:PROX5.5-30L:DIST4 TI | In distribution | |
| 120L:PROX6-35L:DIST4 TI | In distribution | |
| 80L:PROX5-20L:DIST4 TI | Length 80 mm | In distribution |
| 100L:PROX5-40L:DIST4.5 TI | In distribution | |
| 80L:PROX5-30L:DIST4.5 TI | In distribution | |
| 80L:PROX6-25L:DIST4.5 TI | In distribution | |
| 80L:PROX6-30L:DIST4.5 TI | In distribution | |
| 90L:PROX5-40L:DIST4 TI | In distribution | |
| Tray, lower Instrument Drawer | In distribution | |
| 110L:PROX5.5-35L:DIST4 TI | In distribution | |
| Driver, screw, T25 | In distribution | |
| 130L:PROX6-30L:DIST4.5 TI | In distribution | |
| 100L:PROX6-40L:DIST4 TI | In distribution | |
| 90L:PROX5-30L:DIST4 TI | In distribution | |
| 90L:PROX6-30L:DIST4.5 TI | In distribution | |
| 80L:PROX5.5-35L:DIST4.5 TI | In distribution | |
| 90L:PROX6-30L:DIST4 TI | In distribution | |
| 80L:PROX5.5-25L:DIST4 TI | In distribution | |
| 100L:PROX5-30L:DIST4.5 TI | In distribution | |
| 110L:PROX6-30L:DIST4.5 TI | In distribution | |
| 90L:PROX5.5-40L:DIST4.5 TI | In distribution | |
| 130L:PROX6-30L:DIST4 TI | In distribution | |
| 90L:PROX5-30L:DIST4.5 TI | In distribution | |
| 90L:PROX5-25L:DIST4 TI | In distribution | |
| 80L:PROX5.5-40L:DIST4 TI | In distribution | |
| 80L:PROX5-40L:DIST4 TI | In distribution | |
| 80L:PROX6-25L:DIST4 TI | In distribution | |
| K-Wire, 1.3mm x 225mm PK 25 | In distribution | |
| 100L:PROX5-40L:DIST4 TI | In distribution | |
| 120L:PROX6-35L:DIST4.5 TI | In distribution | |
| 90L:PROX5-25L:DIST4.5 TI | In distribution | |
| 80L:PROX5.5-40L:DIST4.5 TI | In distribution | |
| 80L:PROX5-40L:DIST4.5 TI | In distribution | |
| 90L:PROX6-25L:DIST4.5 TI | In distribution | |
| 100L:PROX6-30L:DIST4 TI | In distribution | |
| 80L:PROX6-40L:DIST4 TI | In distribution | |
| Gauge, 1.3mm K-wire | In distribution | |
| 110L:PROX5.5-25L:DIST4.5 TI | In distribution |
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 |
|---|---|
| K200226 | 2020-06-26 |
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.