PediNail Intramedullary Platform
Captured Screw Driver Shaft, 3.5MM, AO, Long
12manufacturers in China registered for this device type
2catalogue 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 | 2018-05-31 |
| Record revised | 2025-07-03 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 01-1501-0039 | In distribution | |
| 01-1501-0040 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Driver, Surgical, Pin | AAP Implantate AG | 18 |
| Orthopediatrics Instrumentation | Orthopediatrics, Corp | 15 |
| 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 |
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.