Panels › Orthopedic › Product code MEH · Class 2
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Regulation 888.3353
1510(k)s in 12 months (160 all time)
1recalls in 12 months (197 all time)
190recalls that name a 510(k)
Top companies in MEH
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 |
| Sep 18, 2008 | Portland Orthopaedics Pty, Ltd. Margron DTC Hip Replacement System; Margron hip - Femoral stem Y+1, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 1-730-061. 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 6+0, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 1-652-000. 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+0, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 1-651-000. 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+0, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 1-650-000. 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+0, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 1-649-000. 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+0, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 1-648-000. 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+0, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 1-647-000. 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+0, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 1-727-000. 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+0, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 1-726-000. 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 neck C+6, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 1-690-000. 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 neck B+4, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 1-689-000. 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 neck C-B, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 1-688-000. 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 neck C-A, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 1-687-000. 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 neck B-A, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 1-686-000. 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 neck CB+6, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 1-685-000. 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 neck C, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 1-658-000. 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 neck B, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 1-656-000. 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 neck A, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 1-654-000. 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 neck AZ, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 1-750-000. 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 neck Z, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 1-747-000. 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 neck Y, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 1-746-000. Product is used for Orthopedic surgery. Terminated |
MEH | K032641 K992815 |
| Jun 12, 2008 | Stryker Howmedica Osteonics Corp. Trident PSL HA Cluster:
40 mm to 72 mm, hip prosthesis component, Stryker Orthopaedics, Howmedica Osteonics Corp, Mahwah, NJ 07430 Terminated |
MEH | K013676 |
| Jun 12, 2008 | Stryker Howmedica Osteonics Corp. Trident PSL Acetabular Shells; Trident PSL HA Solid Back,
40 mm to 73 mm, hip prosthesis component, Stryker Orthopaedics, Howmedica Osteonics Corp, Mahwah, NJ 07430 Terminated |
MEH | K013676 |
| Jun 12, 2008 | Stryker Howmedica Osteonics Corp. Trident Hemispherical Multi
Arc Deposited;
Hydroxylapatite Coated; Multiholed; Use with Size A insert;
hip prosthesis component, Stryker Orthopaedics, Howmedica Osteonics Corp, Mahwah, NJ 07430 Terminated |
MEH | K013676 |
| Jun 12, 2008 | Stryker Howmedica Osteonics Corp. Trident Hemispherical HA Cluster, 42 mm - 74mm
Arc Deposited;
Hydroxylapatite Coated; Multiholed; Use with Size A insert; hip prosthesis component, Stryker Orthopaedics, Howmedica Osteonics Corp, Mah Terminated |
MEH | K013676 |
| Jun 12, 2008 | Stryker Howmedica Osteonics Corp. Trident Hemispherical Cluster;
42mm - 74 mm
Arc Deposited;
Hydroxylapatite Coated; Multiholed; Use with Size A insert; hip prosthesis component, Stryker Orthopaedics, Howmedica Osteonics Corp, Mahwah Terminated |
MEH | K013676 |
| Jun 12, 2008 | Stryker Howmedica Osteonics Corp. Trident Hemispherical Acetabular Shells HA Solid BK
42mm- 74mm;
Arc Deposited;
Hydroxylapatite Coated; Multiholed; Use with Size A insert; hip prosthesis component, Stryker Orthopaedics, Howmedica Os Terminated |
MEH | K013676 |
| Jun 12, 2008 | Stryker Howmedica Osteonics Corp. Trident Hemispherical Solid BK Acetabular Shells;
42mm to 74mm,
Hydroxylapatite Coated; Multiholed; Use with Size A insert; hip prosthesis component, Stryker Orthopaedics, Howmedica Osteonics Corp, M Terminated |
MEH | K013676 |
| Oct 25, 2007 | Stryker Howmedica Osteonics Corp. HA Solid Back Acetabular Shell;
Arc Deposited HA Coated Included Dome hole Plug; Hip prosthesis component.
Sterile; made in USA;
Howmedica Osteonics Corp.;
325 Corporate Drive;
Mahwah, NJ 07430
A Su Terminated |
MEH | K983382 |
| Oct 25, 2007 | Stryker Howmedica Osteonics Corp. Trident PSL HA Cluster Acetabular Shell;
Arc Deposited HA Coated Cluster Screw Holes. Hip prosthesis component.
Howmedica Osteonics Corp.
325 Corporate Drive;
Mahwah, NJ 07430;
A subsidiary of Stry Terminated |
MEH | K983382 |
| Sep 26, 2007 | Stryker Howmedica Osteonics Corp. Trident PSL Acetabular Shell;Arc Deposited;Hydroxylapatite Coated;Cluster Screw Holes;Howmedica Osteonics Corp.,
325 Corporate DriveMahway, NJ 07430 Terminated |
MEH | K983382 |
| Jan 28, 2003 | Stryker Howmedica Osteonics Restoration #8 HA Hip Stem, Catalog No. 6013-1216 and Restoration #8 HA Hip Stem, Catalog No. 6013-1218. Terminated |
MEH | K944836 |
| Dec 19, 2002 | Howmedica Osteonics Corp Citation TMZF HA Hip Stem Left (Femoral Hip Prosthesis)
Catalog No. 6265-5106 Terminated |
MEH | K993768 |
| Dec 19, 2002 | Howmedica Osteonics Corp Citation TMZF HA Hip Stem Right (Femoral Hip Prosthesis)
Catalog No. 6265-5116 Terminated |
MEH | K993768 |
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