R&D Batteries, Inc.
9.6 Volt .65Ah NiCd-Stryker Insert
10manufacturers in China registered for this device type
18catalogue numbers in this listing
1510(k) clearance
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 | R & D Batteries, Inc., United States |
|---|---|
| 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 | Contract manufacturer, Manufacturer |
| 510(k) | K933337 |
| Record published | 2024-01-01 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5760 | In distribution | |
| 6450 | In distribution | |
| 6581 | In distribution | |
| 6018 | In distribution | |
| 5982 | In distribution | |
| 6421 | In distribution | |
| 6020 | In distribution | |
| 5948 | In distribution | |
| 5145 | In distribution | |
| G42EP | In distribution | |
| 5983 | In distribution | |
| 8214-3040C | In distribution | |
| 5807 | In distribution | |
| 6224 | In distribution | |
| 6484 | In distribution | |
| 5948-I | In distribution | |
| 6500 | In distribution | |
| 5145-I | 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 |
| 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 |
| Global Steptech | Depuy (Ireland) | 12 |
Showing 12 of 64. All products under Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K933337 | 1994-04-05 |
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.