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Battery-Powered Instruments Charged Through Sterile Barriers

FDA product code SAM · 1 cleared devices

Class 1 General, Plastic Surgery
Regulation
21 CFR 878.4820
Review panel
OR
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2024-04-04 – 2024-04-04

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.

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