FDA.reportPublic FDA data

NAVBIT PTY LTD

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30160759693016075969NAVBIT PTY LTD1N2026-01-01Suite 201, National Innovation Centre 4 Cornwallis Street South Eveleigh New South Wales AU 2015

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
09369998068180Navbit Sprint_Supine - Cup Alignment Technology for Hip Replacement+61433482325dave.thomson@navbit.com
09369998142903Navbit Sprint_Lateral - Cup Alignment Technology for Hip Replacement+61433482325dave.thomson@navbit.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2910521422023960K261410Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit))OLO2026-07-30
2910522020713662K243447Rapid Surgical Plan (RSP-SW-001)LLZ2024-12-05

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
OLO12026-07-30
LLZ12024-12-05

PMN#

GUDID#