FDA 510(k)

Rapid Surgical Plan (RSP-SW-001)

K-Number: K243447 · 2024-12-05

Decision Date2024-12-05

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Rapid Surgical Plan (RSP-SW-001) is a medical device manufactured by Navbit Pty, Ltd.. It received FDA 510(k) clearance on 2024-12-05 under approval number K243447. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Rapid Surgical Plan (RSP-SW-001)?

Rapid Surgical Plan (RSP-SW-001) is a medical device that received FDA 510(k) clearance on 2024-12-05. It is manufactured by Navbit Pty, Ltd.. The 510(k) number is K243447.

When was Rapid Surgical Plan (RSP-SW-001) approved by the FDA?

Rapid Surgical Plan (RSP-SW-001) received FDA 510(k) clearance on 2024-12-05, under approval number K243447.

What company makes Rapid Surgical Plan (RSP-SW-001)?

Rapid Surgical Plan (RSP-SW-001) is manufactured by Navbit Pty, Ltd..

What is the FDA product code for Rapid Surgical Plan (RSP-SW-001)?

The FDA product code for Rapid Surgical Plan (RSP-SW-001) is LLZ.

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Official Source

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