Free Gliding Scfe Screw System
FULL SCFE IMPLANT & INSTRUMENT CASE 2nd Gen.
31manufacturers in China registered for this device type
43catalogue numbers in this listing
2recalls on this code
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 | Orthopediatrics Canada ULC, Canada |
|---|---|
| FDA product code | HWC |
| Device type | Screw, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Establishment | Manufacturer |
| 510(k) | K131591 |
| Record published | 2016-12-07 |
| Record revised | 2025-05-13 (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 |
| Label carries | lot or batch number, serial number |
| Storage | Special storage condition: keep at room temperature |
| Sizes | Length 48 to 102 mm; outer diameter 6.5 to 7.3 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SCF-CSF200 | In distribution | |
| SCF-T65-52S/54L | Outer Diameter 6.5 mm | In distribution |
| SCF-M73-ML | Outer Diameter 7.3 mm | In distribution |
| SCF-MC-073 | Outer Diameter 7.3 mm | In distribution |
| SCF-CSF550 | In distribution | |
| SCF-F73-64S/66L | Outer Diameter 7.3 mm | In distribution |
| SCF-F65-88S/90L | Outer Diameter 6.5 mm | In distribution |
| SCF-T73-48S/50L | Length 48 mm | In distribution |
| SCF-F73-84S/86L | Length 84 mm | In distribution |
| SCF-F65-68S/70L | Outer Diameter 6.5 mm | In distribution |
| SCF-T73-52S/54L | Length 52 mm | In distribution |
| SCF-F73-88S/90L | Length 88 mm | In distribution |
| SCF-F65-76S/78L | Length 78 mm | In distribution |
| SCF-M73-L | Outer Diameter 7.3 mm | In distribution |
| SCF-CSF400 | In distribution | |
| SCF-F65-64S/66L | Outer Diameter 6.5 mm | In distribution |
| SCF-F65-60S/62L | Length 62 mm | In distribution |
| SCF-M65-ML | Outer Diameter 6.5 mm | In distribution |
| SCF-F65-80S/82L | Outer Diameter 6.5 mm | In distribution |
| SCF-M65-L | Outer Diameter 6.5 mm | In distribution |
| SCF-F65-92S/94L | Outer Diameter 6.5 mm | In distribution |
| SCF-M73-MS | Outer Diameter 7.3 mm | In distribution |
| SCF-F65-84S/86L | Length 84 mm | In distribution |
| SCF-F73-76S/78L | Length 76 mm | In distribution |
| SCF-M65-MS | Outer Diameter 6.5 mm | In distribution |
| SCF-F73-80S/82L | Length 82 mm | In distribution |
| SCF-MC-065 | Outer Diameter 6.5 mm | In distribution |
| SCF-F65-96S/98L | Outer Diameter 6.5 mm | In distribution |
| SCF-M65-S | Outer Diameter 6.5 mm | In distribution |
| SCF-CCF230 | In distribution | |
| SCF-T65-48S/50L | Outer Diameter 6.5 mm | In distribution |
| SCF-F65-100S/102L | Length 102 mm | In distribution |
| SCF-F65-72S/74L | Length 72 mm | In distribution |
| SCF-F73-100S/102L | Length 100 mm | In distribution |
| SCF-F73-92S/94L | Length 92 mm | In distribution |
| SCF-F73-96S/98L | Length 98 mm | In distribution |
| SCF-T65-56S/58L | Length 56 mm | In distribution |
| SCF-F73-60S/62L | Length 62 mm | In distribution |
| SCF-F73-72S/74L | Length 72 mm | In distribution |
| SCF-F73-68S/70L | Outer Diameter 7.3 mm | In distribution |
| SCF-T73-56S/58L | Length 56 mm | In distribution |
| SCF-CMCSFRENT | In distribution | |
| SCF-M73-S | Outer Diameter 7.3 mm | 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
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Orthopediatrics Canada ULC | 510(k) number | 2015-10-20 | Class II | Unknown/Undetermined by firm | SCFE Driver’s threaded shaft broke close to the knob when a manual force was applied during the fixation of the screw. | 4 units distributed in the US | 2016-08-16 |
| Orthopediatrics Canada ULC | 510(k) number | 2015-06-15 | Class II | Reprocessing Controls | SCFE Drivers of the Free-Gliding SCFE Screw System are recalled because the handle of the instruments may detach from the shaft if high torques are applied in counter-clockwise rotation. | 4 units | 2015-12-29 |
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.