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510(k) Data Aggregation
K Number
K202326Device Name
BESPA Charcot System
Manufacturer
Date Cleared
2021-11-09
(449 days)
Product Code
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
Bespa Global, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The BESPA Charcot System is indicated for fracture fixation, reconstruction procedures, arthrodesis, and osteotomies of various bones and bone fragments in the foot and ankle, including metatarsals and tarsals. For example, medial and/or lateral column fusion as a result of neuropathic osteoarthropathy (Charcot). The BEPSA Charcot System is intended for use in adult populations. The device is for prescription use only.
Device Description
The BESPA Charcot System is offered non-sterile and consists of implants and system-specific instruments.
The Segmental Column is composed of various modular cylindrical components which screw together to create an implant assembly of the surgeon's desired features. The system contains transverse screws of various lengths. The implant construct has a compression capability.
All implants are made of titanium alloy.
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