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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthopedic Stereotaxic Instrument
510(k) Number K261410
Device Name Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit))
Applicant
Suite 201, National Innovation Centre
4 Cornwallis St.
South Eveleigh
Nsw,  AU Australia
Applicant Contact David Thomson
Correspondent
Suite 201, National Innovation Centre
4 Cornwallis St.
South Eveleigh
Nsw,  AU Australia
Correspondent Contact David Thomson
Regulation Number882.4560
Classification Product Code
OLO  
Date Received04/30/2026
Decision Date 07/30/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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