Giro Growth Modulation System
4.5 coupling assembled on the cable loop side
31manufacturers in China registered for this device type
49catalogue 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) | K220190 |
| Record published | 2022-11-28 |
| Record revised | 2025-05-13 (version 6) |
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 15 to 80 mm; lumen/inner diameter 3.35 to 6.3 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| GRO-45CL | Lumen/Inner Diameter 6.3 mm | In distribution |
| GRO-CS35-35 | Length 35 mm | In distribution |
| GRO-CS35-15 | Length 15 mm | In distribution |
| GRO-FP45-35 | Lumen/Inner Diameter 3.35 mm | In distribution |
| GRO-CS45-30 | Length 30 mm | In distribution |
| GRO-FP60-85 | Length 75 mm | In distribution |
| GRO-MP45-25 | Length 25 mm | In distribution |
| GRO-FP60-50 | Length 40 mm | In distribution |
| GRO-CS60-35 | Length 35 mm | In distribution |
| GRO-CS60-20 | Length 20 mm | In distribution |
| GRO-CYF250-35 | In distribution | |
| GRO-CS60-30 | Length 30 mm | In distribution |
| GRO-MP45-35 | Length 35 mm | In distribution |
| GRO-FP45-45 | Lumen/Inner Diameter 3.35 mm | In distribution |
| GRO-CS45-20 | Length 20 mm | In distribution |
| GRO-CS35-25 | Length 25 mm | In distribution |
| GRO-FP45-40 | Lumen/Inner Diameter 3.35 mm | In distribution |
| GRO-A60-028 | Length 28 mm | In distribution |
| GRO-CS35-30 | Length 30 mm | In distribution |
| GRO-FP45-70 | Length 60 mm | In distribution |
| GRO-IMF150-45 | In distribution | |
| GRO-FP45-55 | Lumen/Inner Diameter 3.35 mm | In distribution |
| GRO-CYF150-60 | In distribution | |
| GRO-FP60-70 | Length 60 mm | In distribution |
| GRO-FP45-75 | Length 65 mm | In distribution |
| GRO-CS45-35 | Length 35 mm | In distribution |
| GRO-CS45-25 | Length 25 mm | In distribution |
| GRO-FP60-80 | Lumen/Inner Diameter 4.35 mm | In distribution |
| GRO-FP45-80 | Length 70 mm | In distribution |
| GRO-FP60-60 | Length 50 mm | In distribution |
| GRO-FP60-55 | Lumen/Inner Diameter 4.35 mm | In distribution |
| GRO-CYF250-60 | In distribution | |
| GRO-CS60-25 | Length 25 mm | In distribution |
| GRO-CYF150-45 | In distribution | |
| GRO-CS35-20 | Length 20 mm | In distribution |
| GRO-FP45-65 | Lumen/Inner Diameter 3.35 mm | In distribution |
| GRO-FP45-60 | Length 50 mm | In distribution |
| GRO-CYF250-45 | In distribution | |
| GRO-IME100-60 | In distribution | |
| GRO-MP60-35 | Length 40 mm | In distribution |
| GRO-FP60-75 | Length 65 mm | In distribution |
| GRO-CS45-15 | Length 15 mm | In distribution |
| GRO-FP60-90 | Length 80 mm | In distribution |
| GRO-FP60-45 | Length 35 mm | In distribution |
| GRO-FP45-30 | Length 20 mm | In distribution |
| GRO-CS60-15 | Length 15 mm | In distribution |
| GRO-FP60-40 | Lumen/Inner Diameter 4.35 mm | In distribution |
| GRO-FP45-50 | Length 40 mm | In distribution |
| GRO-FP60-65 | Length 55 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
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 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 |
| 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.