510(k) K983382 ยท MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
OSTEONICS HA GENERATION II ACETABULAR COMPONENT SYSTEM
| Applicant | Osteonics Corp., Allendale NJ, US |
| Decision | Substantially Equivalent, Dec 11, 1998 |
| Received | Sep 25, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983382
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 3, 2015 | Stryker Howmedica Osteonics Corp. Trident PSL HA Solid Back 50 mm
Includes Dome Hole Plug
Ref 540-11-50E
Intended for cementless application in a total hip arthroplasty procedure. This system is a two piece ( a shell and a liner) de Terminated |
MEH | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.