Orthopediatrics Instrumentation
Direct Measuring Device - 3.2 x 300mm Wires
12manufacturers in China registered for this device type
15catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (5), Zhejiang (4), Shanghai (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
| Planet(Shanghai) International Co., Ltd. | Shanghai | Shanghai | Exporter | 93 |
| Planet (Anhui) International Co., Ltd. | Chuzhou | Anhui | Exporter | 80 |
| Ningbo Tianbo First AID Product Co., Ltd. | Ningbo | Zhejiang | Repacker / relabeller | 66 |
| Dongguan City Ruimi Gift Products Co Ltd | Dongguan | Guangdong | Repacker / relabeller | 62 |
| Firstar Healthcare Company Limited (Guangzhou) | Guangzhou | Guangdong | Contract manufacturer | 57 |
| Yiwu Ori-Power Medtech Co., Ltd. | Yiwu | Zhejiang | Contract manufacturer | 46 |
| Guangdong Comfort Medical Products Co., Ltd. | Jiangmen | Guangdong | Repacker / relabeller | 28 |
| Guizhou Zirui Technology Co., Ltd. | Tongzi County, Zunyi | Guizhou | Manufacturer | 4 |
Record
| Listed by | Orthopediatrics, Corp, United States |
|---|---|
| FDA product code | GFC |
| Device type | Driver, Surgical, Pin |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4820 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-03-05 |
| Record revised | 2020-03-17 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Distribution end date | 2021-09-30 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 01-1402-0021 | In distribution | |
| 01-1400-0175 | In distribution | |
| 01-1400-0124 | In distribution | |
| 01-1402-0022 | In distribution | |
| 01-1400-0127 | In distribution | |
| 01-1400-0511 | In distribution | |
| 01-1400-0126 | In distribution | |
| 01-1400-0506 | In distribution | |
| 01-1400-0128 | In distribution | |
| 01-1400-0129 | In distribution | |
| 01-1400-0375 | In distribution | |
| 01-1400-0280 | In distribution | |
| 01-1400-0509 | In distribution | |
| 01-1400-0205 | In distribution | |
| 01-1402-0021 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Driver, Surgical, Pin | AAP Implantate AG | 18 |
| PIN Driver | Gebr. Brasseler Gmbh & Co. KG | 13 |
| Driver, Surgical, Pin | Synthes Gmbh | 12 |
| Consensus Knee System/Revision Knee System | Shalby Advanced Technologies, Inc. | 9 |
| PIN Driver/Bone Tamp | Sontec Instruments, Inc. | 8 |
| Komet PIN Driver | Gebr. Brasseler Gmbh & Co. KG | 8 |
| Broken Screw Removal Instruments | Orthopediatrics, Corp | 7 |
| tangis | Nvision Biomedical Technologies, Inc | 6 |
| Tahoe Unicompartmental Knee System | Shalby Advanced Technologies, Inc. | 4 |
| Power Torque Instrumentation | Orthopediatrics, Corp | 4 |
| Pediatric Nailing Platform Femur | Orthopediatrics, Corp | 3 |
| AnyPlus® | GS Medical Co., Ltd. | 3 |
Showing 12 of 41. All products under Driver, Surgical, Pin
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.