510(k) K013676 ยท MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
TRIDENT HEMISPHERICAL ACETABULAR SHELLS
| Applicant | Howmedica Osteonics Corp., Allendale NJ, US |
| Decision | Substantially Equivalent, Dec 5, 2001 |
| Received | Nov 7, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K013676
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 13, 2009 | Stryker Howmedica Osteonics Corp. Trident Hemispherical Acetabular Shell; 72mm, Arc Deposited, Hydroxylapatite Coated, Multi holed; Sterile; Stryker, France.
Single use devices intended for cementless fixation within the prepared ace Terminated |
MEH | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.