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FDA 510(k)

PEEK RCI Screw; Bio-Composite Screw; SignaLoc Screw

K-Number: K230655 · 2023-05-03

ApplicantSignature Orthopaedics Pty, Ltd.
Decision Date2023-05-03
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PEEK RCI Screw; Bio-Composite Screw; SignaLoc Screw is a medical device manufactured by Signature Orthopaedics Pty, Ltd.. It received FDA 510(k) clearance on 2023-05-03 under approval number K230655. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PEEK RCI Screw; Bio-Composite Screw; SignaLoc Screw?

PEEK RCI Screw; Bio-Composite Screw; SignaLoc Screw is a medical device that received FDA 510(k) clearance on 2023-05-03. It is manufactured by Signature Orthopaedics Pty, Ltd.. The 510(k) number is K230655.

When was PEEK RCI Screw; Bio-Composite Screw; SignaLoc Screw approved by the FDA?

PEEK RCI Screw; Bio-Composite Screw; SignaLoc Screw received FDA 510(k) clearance on 2023-05-03, under approval number K230655.

What company makes PEEK RCI Screw; Bio-Composite Screw; SignaLoc Screw?

PEEK RCI Screw; Bio-Composite Screw; SignaLoc Screw is manufactured by Signature Orthopaedics Pty, Ltd..

What is the FDA product code for PEEK RCI Screw; Bio-Composite Screw; SignaLoc Screw?

The FDA product code for PEEK RCI Screw; Bio-Composite Screw; SignaLoc Screw is MBI.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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