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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 the device name listed in this FDA 510(k) record. The listed applicant is Signature Orthopaedics Pty, Ltd.. It received FDA 510(k) clearance on 2023-05-03 under 510(k) 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. The listed applicant is Signature Orthopaedics Pty, Ltd.. The 510(k) number is K230655.

When did PEEK RCI Screw; Bio-Composite Screw; SignaLoc Screw receive FDA 510(k) clearance?

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

Who is the listed applicant for PEEK RCI Screw; Bio-Composite Screw; SignaLoc Screw?

The FDA 510(k) record lists Signature Orthopaedics Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.

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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