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FDA 510(k)

Rapid Surgical Plan (RSP-SW-001)

K-Number: K243447 · 2024-12-05

ApplicantNavbit Pty, Ltd.
Decision Date2024-12-05
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Rapid Surgical Plan (RSP-SW-001) is the device name listed in this FDA 510(k) record. The listed applicant is Navbit Pty, Ltd.. It received FDA 510(k) clearance on 2024-12-05 under 510(k) 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. The listed applicant is Navbit Pty, Ltd.. The 510(k) number is K243447.

When did Rapid Surgical Plan (RSP-SW-001) receive FDA 510(k) clearance?

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

Who is the listed applicant for Rapid Surgical Plan (RSP-SW-001)?

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

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.

Other records listing Navbit Pty, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K200376Navbit Sprint System- Supine Registration, Navbit Sprint Kit - Lateral Registration

Related Devices (Code: LLZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262449AdvaViewADVAHEALTH SOLUTIONS, LLCK261916NeuroQuant PETCortechs Labs, Inc.K260936RadioViewAINeurocareai, Inc. (Dba Savelife.Ai)K260588Cleerly LABSCleerly, Inc.K262462TheraSphere 360™ Y-90 Management PlatformBoston Scientific CorporationK262143ImageGrid StreamVueCandelis, Inc.

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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