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510(k) Data Aggregation
K Number
K161334Device Name
RASL Repair Kit
Manufacturer
Date Cleared
2017-02-09
(273 days)
Product Code
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
RADICLE ORTHOPAEDICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The RASL Repair Kit is intended to provide fixation and anatomically reduce two bones or bone portions. Specifically, these indications include acute or chronic, static or dynamic scapholunate instability in the absence of significant capitolunate osteoarthritis, scapholunate ligament repair, scapholunate reduction, lunotriquetral ligament repair, lunotriquetral reduction, and carpal instability.
Device Description
The Radicle Orthopaedics RASL Repair Kit is an implant and instrument system designed to treat scapholunate ligament ("SLIL") ruptures. The RASL Repair Kit implants are made from titanium alloy, Ti-6Al-EV ELI, per ASTM F136. Instruments are made from surgical-grade stainless steel according to ASTM F899. The entire kit is supplied non-sterile. Instruments are meant to be reusable.
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