Company ยท US
Portland Orthopaedics Pty, Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2000 to 2007. Name variants (Inc, Corp, punctuation) are merged.
6510(k) clearances (0 in 12 months)
71recalls (0 in 12 months)
71recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | 73 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 1 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 1 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 1 |
| MAY | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 12, 2007 | K063278 | PORTLAND COBALT CHROME FEMORAL HEAD Portland Orthopaedics Limited | JDI |
| Sep 1, 2006 | K061564 | PORTLAND CERAMIC (BIOLOX-FORTE) FEMORAL HEAD Portland Orthopaedics Pty. , Ltd. | LZO |
| Jul 20, 2006 | K053417 | M-COR HIP REPLACEMENT SYSTEM Portland Orthopaedics Pty. , Ltd. | LPH |
| Oct 7, 2005 | K051844 | EQUATOR PLUS ACETABULAR CUP SYSTEM Portland Orthopaedics Pty. , Ltd. | MAY |
| Jan 20, 2004 | K032641 | MODIFICATION TO: THE MARGRON HIP REPLACEMENT SYSTEM Portland Orthopaedics Pty. , Ltd., AU | MEH |
| Feb 7, 2000 | K992815 | THE MARGRON HIP REPLACEMENT SYSTEM Portland Orthopaedics Pty. , Ltd., AU | MEH |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip extension module ZZ7, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-731-008. Product is used for Orthopedic surgery. Terminated |
MEH | K032641 K992815 |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip extension module ZZ6, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-731-007. Product is used for Orthopedic surgery. Terminated |
MEH | K032641 K992815 |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip extension module YY7, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-731-006. Product is used for Orthopedic surgery. Terminated |
MEH | K032641 K992815 |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip extension module YY6, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-731-005. Product is used for Orthopedic surgery. Terminated |
MEH | K032641 K992815 |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip extension module CC7, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-205. Product is used for Orthopedic surgery. Terminated |
MEH | K032641 K992815 |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip extension module BB7, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-204. Product is used for Orthopedic surgery. Terminated |
MEH | K032641 K992815 |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip extension module BB6, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-203. Product is used for Orthopedic surgery. Terminated |
MEH | K032641 K992815 |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip extension module AA7, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-202. Product is used for Orthopedic surgery. Terminated |
MEH | K032641 K992815 |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip extension module AA6, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-201. Product is used for Orthopedic surgery. Terminated |
MEH | K032641 K992815 |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture holes 6+6, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-966. Terminated |
MEH | K032641 K992815 |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture holes 6+5, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-965. Terminated |
MEH | K032641 K992815 |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture holes 6+4, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-964. Product is used for Orthopedic surgery. Terminated |
MEH | K032641 K992815 |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture holes 6+3, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-963. Product is used for Orthopedic surgery. Terminated |
MEH | K032641 K992815 |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture holes 5+6, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-956. Product is used for Orthopedic surgery. Terminated |
MEH | K032641 K992815 |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture holes 5+5, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-955. Product is used for Orthopedic surgery. Terminated |
MEH | K032641 K992815 |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture holes 5+4, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-954. Product is used for Orthopedic surgery. Terminated |
MEH | K032641 K992815 |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture holes 5+3, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-953. Product is used for Orthopedic surgery. Terminated |
MEH | K032641 K992815 |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture holes 4+5, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-945. Product is used for Orthopedic surgery. Terminated |
MEH | K032641 K992815 |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture holes 4+4, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-944. Product is used for Orthopedic surgery. Product Terminated |
MEH | K032641 K992815 |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture holes 4+3, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-943. Product is used for Orthopedic surgery. Terminated |
MEH | K032641 K992815 |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture holes 3+5, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-935. Product is used for Orthopedic surgery. Terminated |
MEH | K032641 K992815 |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture holes 3+4, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-934. Product is used for Orthopedic surgery. Terminated |
MEH | K032641 K992815 |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture holes 3+3, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-933. Product is used for Orthopedic surgery. Terminated |
MEH | K032641 K992815 |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture holes 2+5, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-925. Product is used for Orthopedic surgery. Terminated |
MEH | K032641 K992815 |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture holes 2+4, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-924. Product is used for Orthopedic surgery. Terminated |
MEH | K032641 K992815 |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture holes 2+3, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-923. Product is used for Orthopedic surgery. Terminated |
MEH | K032641 K992815 |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture holes 1+5, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-915. Product is used for Orthopedic surgery. Terminated |
MEH | K032641 K992815 |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture holes 1+4, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-914. Product is used for Orthopedic surgery. Terminated |
MEH | K032641 K992815 |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture holes 1+3, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-913. Product is used for Orthopedic surgery. Terminated |
MEH | K032641 K992815 |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture holes Z+5, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 1-730-975. Product is used for Orthopedic surgery. Terminated |
MEH | K032641 K992815 |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture holes Z+4, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 1-730-974. Product is used for Orthopedic surgery. Terminated |
MEH | K032641 K992815 |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture holes Z+3, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 1-730-973. Product is used for Orthopedic surgery. Terminated |
MEH | K032641 K992815 |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture holes Y+5, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 1-730-965. Product is used for Orthopedic surgery. Terminated |
MEH | K032641 K992815 |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture holes Y+4, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 1-730-964. Product is used for Orthopedic surgery. Terminated |
MEH | K032641 K992815 |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture holes Y+3, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 1-730-963. Product is used for Orthopedic surgery. Terminated |
MEH | K032641 K992815 |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral stem 6+2, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-062. Product is used for Orthopedic surgery. Terminated |
MEH | K032641 K992815 |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral stem 6+1, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-061. Product is used for Orthopedic surgery. Terminated |
MEH | K032641 K992815 |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral stem 5+2, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-052. Product is used for Orthopedic surgery. Terminated |
MEH | K032641 K992815 |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral stem 5+1, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-051. Product is used for Orthopedic surgery. Terminated |
MEH | K032641 K992815 |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral stem 4+2, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-042. Product is used for Orthopedic surgery. Terminated |
MEH | K032641 K992815 |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral stem 4+1, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-041. Product is used for Orthopedic surgery. Terminated |
MEH | K032641 K992815 |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral stem 3+2, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-032. Product is used for Orthopedic surgery. Terminated |
MEH | K032641 K992815 |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral stem 3+1, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-031. Product is used for Orthopedic surgery. Terminated |
MEH | K032641 K992815 |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral stem 2+2, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-022. Product is used for Orthopedic surgery. Terminated |
MEH | K032641 K992815 |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral stem 2+1, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-021. Product is used for Orthopedic surgery. Terminated |
MEH | K032641 K992815 |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral stem 1+2, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-012. Product is used for Orthopedic surgery. Terminated |
MEH | K032641 K992815 |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral stem 1+1, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-011. Product is used for Orthopedic surgery. Terminated |
MEH | K032641 K992815 |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral stem Z+2, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 1-730-072. Product is used for Orthopedic surgery. Terminated |
MEH | K032641 K992815 |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral stem Z+1, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 1-730-071. Product is used for Orthopedic surgery. Terminated |
MEH | K032641 K992815 |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral stem Y+2, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 1-730-062. Product is used for Orthopedic surgery. Terminated |
MEH | K032641 K992815 |
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