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510(k) Data Aggregation
K Number
K240071Device Name
Peleton Universal Single Use Power System and Attachments
Manufacturer
Date Cleared
2024-04-04
(85 days)
Product Code
Regulation Number
878.4820Why did this record match?
Applicant Name (Manufacturer) :
Peleton Surgical
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Peleton Surgical Single Use Power Tool System is a battery driven tool system for use in Trauma, Orthopaedic and Cardio related Surgical Procedures involving drilling, reaming, pin & wire placement and cutting of bone and hard tissue.
Device Description
The Peleton Surgical Universal Power System is a battery powered tool for use in cardio-ortho related surgical procedures and is designed for the efficient cutting of bone and hard tissue. Due to the sterile barrier charging, the device is readily charged and available for immediate use in the surgical setting. The Peleton Surgical Universal Power System's lithium-ion polymer battery is always fully charged with more power than is needed for any surgery. Surgical attachments are easily interchangeable and cover every aspect of large bone surgical procedures, including, cutting reaming, sawing and surgical pin insertion and removal etc.
The Peleton Surgical Universal Power System is a double sterile barrier packaging system that includes internal and external electrical charging port features. This double sterile barrier packaging system consists of the device and its components being sealed inside an inner tray with a charging the device and the inner tray charging port. The sealed inner tray is then sealed inside an outer tray with a charging cable connecting the inner tray charging port to the outer tray charging port. The charging port includes various components to ensure a tight seal that maintains the proper sterile barrier.
The Peleton Surgical Universal Power System includes a variety of metallic attachments (ASTM F899) that are used in clinical procedures. The system is compatible with a Sternum Saw, Reciprocating Saw, Keyless Jacobs Chuck, Multi-Fit Hudson/Trinkle Reamer, Cannulated Pin and Wire Driver and Quick Release Drill Chuck. Each attachment is compatible with universal saws, drill bits and reamers from manufacturers of orthopedic accessories.
The single use Peleton Surgical Universal Power System was designed to instantly be ready to the surgical field, reducing operating room time, eliminating the need for multiple batteries/changes on extended cases, eliminating the risk of potential bioburden from improper cleaning from previous cases and reducing the amount of time needed to properly clean and re-sterilize the reusable system.
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