The Agee Digit Widget® (DWD-232) is a threaded fixation pin used as part of an external fixation system for the treatment of PIP joint flexion contractures. Included Items: One item per order Quantity Included: 1 Set Per Box Condition: New Expiration: 2029-09-01 Specifications: - Manufacturer: Hand Biomechanics Lab Inc - Brand Name: Agee Digit Widget® - Reference/Part No.: DWD-232 - GMDN Code: 32854 - GMDN Term: Orthopaedic bone pin, non-bioabsorbable - Product Code: JDW – Pin, Fixation, Threaded - Device Class: II - Regulation Number: 888.3040 - Medical Specialty: Orthopedic - Premarket Submission: K992970 - UDI (Primary): 00861994000212 (GS1) - Quantity per Package: 1 - Expiration Date: 2029-09-01 - Intended Use: External fixation system for treatment of PIP joint flexion contractures The Agee Digit Widget® DWD-232 is classified as a non-bioabsorbable orthopaedic bone pin (GMDN 32854) and is indicated for use as part of an external fixation system targeting proximal interphalangeal (PIP) joint flexion contractures. As a threaded fixation pin, it is designed to be drilled into bone to provide stabilization, and may support bone fracture management, bone grafting, osteotomy, or arthrodesis applications consistent with its GMDN classification. The device is manufactured by Hand Biomechanics Lab Inc and cleared under 510(k) submission K992970. It is a Class II device regulated under 21 CFR 888.3040. The product carries a lot/batch number and has an expiration date of September 1, 2029. Each base package contains one device unit. Features: - Threaded fixation pin design for secure bone engagement - Non-bioabsorbable construction - Indicated for external fixation of PIP joint flexion contractures - Lot/batch number traceability - 510(k) cleared (K992970) - Class II orthopedic device per 21 CFR 888.3040 Applications: - Treatment of proximal interphalangeal (PIP) joint flexion contractures - External fixation of bone fractures - Bone graft stabilization - Osteotomy fixation - Arthrodesis support WARRANTY/RETURNS: -No warranty is expressed or implied with the sale of this item(s). -No returns on disposables, surgical implants or disposables. "The sale of this item may be subject to regulation by the U.S. Food and Drug Administration and local regulatory agencies. If so, do not bid on this item unless you are an authorized purchaser. If the item is subject to FDA regulation, I will verify your status as an authorized purchaser of this item before shipping of the item."