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510(k) Data Aggregation
K Number
K163593Device Name
Additive Orthopaedics Bunion System
Manufacturer
Additive Orthopaedics, LLC.
Date Cleared
2017-06-20
(181 days)
Product Code
HRS, HWC
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
Additive Orthopaedics, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Additive Orthopaedics Bunion System is indication and fusion of fractures, ostotomies and arthrodesis of small bones such as the foot and ankle.
The Additive Orthopaedics Bunion System is indicated for alignment, stabilization and fusion of fractures, osteotomies and arthrodesis of small bones such as the foot and ankle.
Device Description
The Additive Orthopaedics Bunion System consists of a plate and screws (both locking and nonlocking) with surgical site preparation and insertion instruments. The devices is intended to be used for fixation following an osteotomy in bunion correction procedures. The plates are additively manufactured from medical grade titanium alloy (Ti-6AL-4V Eli). The screws are manufactured from medical grade titanium alloy. (Ti-6AL-4V). The implants are provided sterile and intended for single use only. The bunion plate comes in 1 individual size and the screws come in 4 lengths.
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