Medical Device Manufacturer · AU , Matraville Nsw

Portland Orthopaedics Pty. , Ltd. - FDA 510(k) Cleared Devices

5 submissions · 5 cleared · Since 2000

Recent clearances: PORTLAND CERAMIC (BIOLOX-FORTE) FEMORAL HEAD, M-COR HIP REPLACEMENT SYSTEM, EQUATOR PLUS ACETABULAR CUP SYSTEM

View 5 510(k) Devices ↓
5
Total
5
Cleared
0
Denied

FDA 510(k) Regulatory Record - Portland Orthopaedics Pty. , Ltd. Orthopedic ✕

5 devices
1-5 of 5
Cleared Sep 01, 2006
PORTLAND CERAMIC (BIOLOX-FORTE) FEMORAL HEAD
K061564 · LZO
Orthopedic · 88d
Cleared Jul 20, 2006
M-COR HIP REPLACEMENT SYSTEM
K053417 · LPH
Orthopedic · 224d
Cleared Oct 07, 2005
EQUATOR PLUS ACETABULAR CUP SYSTEM
K051844 · MAY
Orthopedic · 92d
Cleared Jan 20, 2004
MODIFICATION TO: THE MARGRON HIP REPLACEMENT SYSTEM
K032641 · MEH
Orthopedic · 146d
Cleared Feb 07, 2000
THE MARGRON HIP REPLACEMENT SYSTEM
K992815 · MEH
Orthopedic · 171d
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