Medical Device Manufacturer · AU , Nsw

Suite 201, National Innovation Centre - FDA 510(k) Cleared Devices

1 submissions · 1 cleared · Since 2026

Recent clearances: Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit))

1

Total

1

Cleared

0

Denied

FDA 510(k) Regulatory Record - Suite 201, National Innovation Centre Orthopedic ✕

1 devices

1-1 of 1

Cleared Jul 30, 2026

Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral...

Orthopedic · 91d