| Device |
battery-powered instruments charged through sterile barriers |
| Regulation Description |
Surgical instrument motors and accessories/attachments. |
| Definition |
Battery-powered instruments intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissues (bones) and soft tissues. Accessories or attachments may include saw blades, drill chuck, pin driver, and reamer. |
| Physical State |
Battery-powered motor and handpiece with modular metallic attachments. The packaging is designed to allow battery charging through the sterile barrier without exposing the device to contamination. |
| Technical Method |
The device uses a battery-powered motor and metallic bone cutting accessories (e.g., saw, drill, reamer attachments) to cut bones and soft tissues. |
| Target Area |
Bones and soft tissues |
| Regulation Medical Specialty |
General & Plastic Surgery |
| Review Panel |
Orthopedic |
|---|
| Product Code | SAM |
|---|
| Premarket Review |
Joint Arthroplasty Devices
(DHT6A)
Joint Arthroplasty Devices
(DHT6A)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
878.4820
|
|---|
| Device Class |
1
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
