K-number	K230655
Device name	PEEK RCI Screw; Bio-Composite Screw; SignaLoc Screw
Applicant	Signature Orthopaedics Pty, Ltd.
Product code	MBI
Device class	Class II
Decision date	May 3, 2023
Decision	Substantially Equivalent
Regulation	888.3040

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Source

View the full FDA submission: accessdata.fda.gov

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PEEK RCI Screw; Bio-Composite Screw; SignaLoc Screw

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