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510(k) Data Aggregation
K Number
K183094Device Name
CyclaPlex Correction System
Manufacturer
Date Cleared
2019-04-26
(170 days)
Product Code
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
Cycla Orthopedics Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The CyclaPlex Correction System is intended for the following surgical indications: to assist in the correction of Hallux Valgus deformity by providing reduction of the 1st intermetatarsal angle.
Device Description
The CyclaPlex Correction Systemis comprised of the Implant, Accessories and Instrument Set. The Implant device pulls the 1ª metatars al inward to wards 2ª metatars al and reduces the internetatarsal angle to medically accepted values. The implant is comprised of two metallic bone screws with internal polymeric housing connected by UHMW polyethylene multiple sutures cord. The cord is looped at Anchor 2 and secured to Anchor 1 by multiple surgical knots. Tw implants (paired) are implanted to reduce local loads on the bone and reduce loads on the device as well.
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