Dynafit System
Snapp-off self compressive screw
31manufacturers in China registered for this device type
113catalogue numbers in this listing
4510(k) clearances naming this product 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 | Neosteo, France |
|---|---|
| FDA product code | HWC |
| Device type | Screw, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Record published | 2018-05-30 |
| Record revised | 2024-02-19 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Device must be stored in a place protected from light and humidity.; Storage environment temperature 15 to 25 °C |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| S27TL24 | Diameter 2.6mm, lenght 24mm | In distribution |
| S18TL38 | Diameter 3.2mm, lenght 38mm | In distribution |
| S25TL22 | Diameter 3.2mm, lenght 22mm | In distribution |
| S18TL30 | Diameter 3.2mm, lenght 30mm | In distribution |
| S25TL28 | Diameter 3.2mm, lenght 28mm | In distribution |
| S16TL30 | Diameter 2.6mm, lenght 30mm | In distribution |
| S19TL24 | Diameter 2.6mm, lenght 24mm | In distribution |
| S15TL40 | Diameter 3.2mm, lenght 40mm | In distribution |
| S25TL30 | Diameter 3.2mm, length 30mm | In distribution |
| S15TL30 | Diameter 3.2mm, lenght 30mm | In distribution |
| S27TL16 | Diameter 2.6mm, lenght 16mm | In distribution |
| S21TL24 | Diameter 2.4mm, lenght 24mm | In distribution |
| S27TL32 | Diameter 2.6mm, lenght 32mm | In distribution |
| S19TL16 | Diameter 2.6mm, lenght 16mm | In distribution |
| S27TL30 | Diameter 2.6mm, lenght 30mm | In distribution |
| S16TL12 | Diameter 2.6mm, lenght 12mm | In distribution |
| S19TL40 | Diameter 2.6mm, lenght 40mm | In distribution |
| S23TL13 | Diameter 2.0mm, lenght 13mm | In distribution |
| S17TL12 | Diameter 2.0mm, lenght 12mm | In distribution |
| S27TL12 | Diameter 2.6mm, lenght 12mm | In distribution |
| S16TL14 | Diameter 2.6mm, lenght 14mm | In distribution |
| S16TL34 | Diameter 2.6mm, lenght 34mm | In distribution |
| S27TL38 | Diameter 2.6mm, lenght 38mm | In distribution |
| S25TL16 | Diameter 3.2mm, lenght 16mm | In distribution |
| S18TL18 | Diameter 3.2mm, lenght 18mm | In distribution |
| S25TL36 | Diameter 3.2mm, lenght 36mm | In distribution |
| S25TL38 | Diameter 3.2mm, lenght 38mm | In distribution |
| S16TL32 | Diameter 2.6mm, lenght 32mm | In distribution |
| S21TL20 | Diameter 2.4mm, lenght 20mm | In distribution |
| S15TL38 | Diameter 3.2mm, lenght 38mm | In distribution |
| S25TL34 | Diameter 3.2mm, lenght 34mm | In distribution |
| S27TL36 | Diameter 2.6mm, lenght 36mm | In distribution |
| S27TL22 | Diameter 2.6mm, lenght 22mm | In distribution |
| S19TL18 | Diameter 2.6mm, lenght 18mm | In distribution |
| S15TL14 | Diameter 3.2mm Lenght 14mm | In distribution |
| S16TL16 | Diameter 2.6mm, lenght 16mm | In distribution |
| S23TL11 | Diameter 2.0mm, lenght 11mm | In distribution |
| S21TL14 | Diameter 2.4mm, lenght 14mm | In distribution |
| S17TL13 | Diameter 2.0mm, lenght 13mm | In distribution |
| S25TL40 | Diameter 3.2mm, lenght 40mm | In distribution |
| S18TL24 | Diameter 3.2mm, lenght 24mm | In distribution |
| S15TL34 | Diameter 3.2mm, lenght 34mm | In distribution |
| S16TL36 | Diameter 2.6mm, lenght 36mm | In distribution |
| S21TL26 | Diameter 2.4mm, lenght 26mm | In distribution |
| S27TL26 | Diameter 2.6mm, lenght 26mm | In distribution |
| S16TL28 | Diameter 2,6mm, lenght 28mm | In distribution |
| S19TL26 | Diameter 2.6mm, lenght 26mm | In distribution |
| S25TL14 | Diameter 3.2mm, lenght 14mm | In distribution |
| S25TL32 | Diameter 3.2mm, lenght 32mm | In distribution |
| S15TL24 | Diameter 3.2mm, lenght 24mm | In distribution |
| S19TL22 | Diameter 2.6mm, lenght 22mm | In distribution |
| S18TL28 | Diameter 3.2mm, lenght 28mm | In distribution |
| S18TL16 | Diameter 3.2mm, lenght 16mm | In distribution |
| S19TL30 | Diameter 2.6mm, lenght 30mm | In distribution |
| S16TL20 | Diameter 2.6mm, lenght 20mm | In distribution |
| S18TL22 | Diameter 3.2mm, lenght 22mm | In distribution |
| S16TL18 | Diameter 2.6mm, lenght 18mm | In distribution |
| S25TL26 | Diameter 3.2mm, lenght 26mm | In distribution |
| S18TL40 | Diameter 3.2mm, lenght 40mm | In distribution |
| S16TL22 | Diameter 2.6mm, lenght 22mm | In distribution |
| S23TL12 | Diameter 2.0mm, lenght 12mm | In distribution |
| S16TL26 | Diameter 2.6mm, lenght 26mm | In distribution |
| S15TL20 | Diameter 3.2mm, lenght 20mm | In distribution |
| S23TL14 | Diameter 2.0mm, lenght 14mm | In distribution |
| S19TL32 | Diameter 2.6mm, lenght 32mm | In distribution |
| S19TL38 | Diameter 2.6mm, lenght 38mm | In distribution |
| S19TL36 | Diameter 2.6mm, lenght 36mm | In distribution |
| S16TL38 | Diameter 2.6mm, lenght 38mm | In distribution |
| S27TL14 | Diameter 2.6mm, lenght 14mm | In distribution |
| S21TL12 | Diameter 2.4mm, lenght 12mm | In distribution |
| S18TL32 | Diameter 3.2mm, lenght 32mm | In distribution |
| S18TL34 | Diameter 3.2mm, lenght 34mm | In distribution |
| S15TL28 | Diameter 3.2mm, lenght 28mm | In distribution |
| S25TL12 | Diameter 3.2mm, lenght 12mm | In distribution |
| S17TL14 | Diameter 2.0mm, lenght 14mm | In distribution |
| S21TL36 | Diameter 2.4mm, lenght 36mm | In distribution |
| S27TL20 | Diameter 2.6mm, lenght 20mm | In distribution |
| S19TL34 | Diameter 2.6mm, lenght 34mm | In distribution |
| S21TL32 | Diameter 2.4mm, lenght 32mm | In distribution |
| S21TL40 | Diameter 2.4mm, lenght 40mm | In distribution |
| S21TL28 | Diameter 2.4mm, lenght 28mm | In distribution |
| S25TL24 | Diameter 3.2mm, lenght 24mm | In distribution |
| S19TL14 | Diameter 2.6mm, lenght 14mm | In distribution |
| S15TL32 | Diameter 3.2mm, lenght 32mm | In distribution |
| S25TL20 | Diameter 3.2mm, lenght 20mm | In distribution |
| S27TL28 | Diameter 2.6mm, lenght 28mm | In distribution |
| S19TL28 | Diameter 2.6mm, lenght 28mm | In distribution |
| S21TL38 | Diameter 2.4mm, lenght 38mm | In distribution |
| S15TL22 | DIameter 3.2mm, lenght 22mm | In distribution |
| S18TL26 | Diameter 3.2mm, lenght 26mm | In distribution |
| S21TL16 | Diameter 2.4mm, lenght 16mm | In distribution |
| S27TL18 | Diameter 2.6mm, lenght 18mm | In distribution |
| S16TL40 | Diameter 2.6mm, lenght 40mm | In distribution |
| S15TL16 | Diameter 3.2mm , lenght 16mm | In distribution |
| S21TL34 | Diameter 2.4mm, lenght 34mm stérile | In distribution |
| S17TL11 | Diameter 2.0mm, lenght 11mm | In distribution |
| S27TL34 | Diameter 2.6mm, lenght 34mm | In distribution |
| S15TL26 | Diameter 3.2mm, lenght 26mm | In distribution |
| S19TL20 | Diameter 2.6mm, lenght 20mm | In distribution |
| S21TL30 | Diameter 2.4mm, lenght 30mm | In distribution |
| S21TL18 | Diameter 2.4mm, lenght 18mm | In distribution |
| S18TL12 | Diameter 3.2mm, lenght 12mm | In distribution |
| S16TL24 | Diameter 2.6mm, lenght 24mm | In distribution |
| S21TL22 | Diameter 2.4mm, lenght 22mm | In distribution |
| S25TL18 | Diameter 3.2mm, lenght 18mm | In distribution |
| S18TL36 | Diameter 3.2mm, lenght 36mm | In distribution |
| S15TL18 | Diameter 3.2mm, lenght 18mm | In distribution |
| S27TL40 | Diameter 2.6mm, lenght 40mm | In distribution |
| S18TL20 | Diameter 3.2mm, lenght 20mm | In distribution |
| S15TL36 | Diameter 3.2mm, lenght 36mm | In distribution |
| S18TL14 | Diameter 3.2mm, lenght 14mm | In distribution |
| S15TL12 | In distribution | |
| S19TL12 | Diameter 2.6mm, lenght 12mm | 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 |
|---|---|
| K191424 | 2019-08-28 |
| K153182 | 2015-11-25 |
| K150772 | 2015-05-08 |
| K131471 | 2013-08-28 |
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.