Giro Growth Modulation System
4.5 coupling assembled on the cable bead side
2manufacturers in China registered for this device type
35catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (1), Jiangsu (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
Record
| Listed by | Orthopediatrics Canada ULC, Canada |
|---|---|
| FDA product code | OBT |
| Device type | Plate, Bone, Growth Control, Pediatric, Epiphysiodesis |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Establishment | Manufacturer |
| 510(k) | K220190 |
| Record published | 2023-11-24 |
| Record revised | 2025-11-20 (version 5) |
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 14 to 40 mm; lumen/inner diameter 6.3 to 7.4 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| GRO-A60-030 | Length 30 mm | In distribution |
| GRO-A45-018 | Length 18 mm | In distribution |
| GRO-A60-020 | Length 20 mm | In distribution |
| GRO-A60-040 | Length 40 mm | In distribution |
| GRO-A45-040 | Length 40 mm | In distribution |
| GRO-A45-036 | Length 36 mm | In distribution |
| GRO-A45-026 | Length 26 mm | In distribution |
| GRO-45BD | Lumen/Inner Diameter 6.3 mm | In distribution |
| GRO-A60-024 | Length 24 mm | In distribution |
| GRO-A60-026 | Length 26 mm | In distribution |
| GRO-A45-038 | Length 38 mm | In distribution |
| GRO-IME100-45 | In distribution | |
| GRO-A45-024 | Length 24 mm | In distribution |
| GRO-A45-028 | Length 28 mm | In distribution |
| GRO-A45-022 | Length 22 mm | In distribution |
| GRO-CSF250-60 | In distribution | |
| GRO-60BD | Lumen/Inner Diameter 7.4 mm | In distribution |
| GRO-A45-032 | Length 32 mm | In distribution |
| GRO-A60-022 | Length 22 mm | In distribution |
| GRO-A60-014 | Length 14 mm | In distribution |
| GRO-A45-016 | Length 16 mm | In distribution |
| GRO-A45-034 | Length 34 mm | In distribution |
| GRO-CSF250-45 | In distribution | |
| GRO-IMF150-60 | In distribution | |
| GRO-A45-030 | Length 30 mm | In distribution |
| GRO-A60-032 | Length 32 mm | In distribution |
| GRO-A45-020 | Length 20 mm | In distribution |
| GRO-A60-036 | Length 36 mm | In distribution |
| GRO-A60-016 | Length 16 mm | In distribution |
| GRO-CSF150 | In distribution | |
| GRO-A60-018 | Length 18 mm | In distribution |
| GRO-A60-034 | Length 34 mm | In distribution |
| GRO-60CL | Lumen/Inner Diameter 7.4 mm | In distribution |
| GRO-A60-038 | Length 38 mm | In distribution |
| GRO-A45-014 | Length 14 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| WishFIX | Wishbone Medical Inc. | 248 |
| EpiFIX | Wishbone Medical Inc. | 240 |
| WishFIX | RED Star Contract Manufacturing Inc. | 124 |
| Guided Growth Plate System | Orthofix SRL | 42 |
| Procedure Kit, Curved 4 hole x 22mm EpiFIX Plate, Instruments and Screws, Ti | Wishbone Medical Inc. | 2 |
| Procedure Kit, Curved 2 hole x 16mm EpiFIX Plate, Instruments and Screws, Ti | Wishbone Medical Inc. | 2 |
| Procedure Kit, Curved 4 hole x 26mm EpiFIX Plate, Instruments and Screws, Ti | Wishbone Medical Inc. | 2 |
| Procedure Kit, Curved 2 hole x 12mm EpiFIX Plate, Instruments and Screws, Ti | Wishbone Medical Inc. | 2 |
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.