Valkyrie® – Power Driver
Catalogue number 01-03-3035, listed by Jeil Medical Corporation, South Korea, under Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment. 10 manufacturers in China are registered for this product code.
10manufacturers in China registered for this device type
1catalogue number
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (4), Zhejiang (1), Guangdong (1). 3 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 |
| Shaanxi Ansen Medical Technology Development Co., Ltd. | Xi’An | Shaanxi | Contract manufacturer | 7 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
| Jiangsu Saikang Medical Equipment Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 34 |
| Jiangsu Yongfa Medical Equipment Technology Co., Ltd. | Zhangjiagang | Jiangsu | Manufacturer | 33 |
| Shanghai NO. 2 Medical College Duhang Medical Equipment Factory | Shanghai | Shanghai | Contract manufacturer | 32 |
| Denjoy Dental Co., Ltd. | Changsha | Hunan | Contract manufacturer | 17 |
| Gavin Biotechnology Co., Ltd. | Jinzhong | Shanxi | Manufacturer | 16 |
| Suzhou Number WIN Medical Technology Co., Ltd. | Zhangjiagang | Jiangsu | Manufacturer | 16 |
Record
| Listed by | Jeil Medical Corporation, South Korea |
|---|---|
| FDA product code | KIJ |
| Device type | Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4820 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-08-12 |
| Record revised | 2024-12-04 (version 3) |
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, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 01-03-3035 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Stainless Steel Guide Wires | Orthopediatrics, Corp | 76 |
| OsteoMed | Osteomed | 36 |
| CS2 Acetabular System | Shalby Advanced Technologies, Inc. | 32 |
| Medinaut MAX | Imedicom Co., Ltd. | 25 |
| MicroAire® | Microaire Surgical Instruments LLC | 20 |
| R&D Batteries, Inc. | R & D Batteries, Inc. | 18 |
| Pediatric Nailing Platform | Tibia | Orthopediatrics, Corp | 17 |
| PNP Tibia | Orthopediatrics, Corp | 14 |
| EZImpactor | Imedicom Co., Ltd. | 13 |
| Insurgical, Inc. | Insurgical, Inc. | 12 |
| Response Spine System | Orthopediatrics, Corp | 12 |
| 3P Hip System | Orthopediatrics, Corp | 12 |
Showing 12 of 64. All products under Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K163308 | 2016-12-27 |
| K101563 | 2010-12-17 |
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.