510(k) K031449 ยท KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
MODIFICATION TO THE TRABECULAR METAL GLENOID - BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION
| Applicant | Implex Corp., Allendale NJ, US |
| Decision | Substantially Equivalent, Sep 23, 2003 |
| Received | May 7, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K031449
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 7, 2005 | Zimmer Inc. Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 40 mm dia. articular surface, small, sterile, for cemented use only in the USA, Cat. no. 00430604000. Terminated |
KWS | None listed |
| Oct 7, 2005 | Zimmer Inc. Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 46 mm dia. articular surface, small, sterile, for cemented use only in the USA, Cat. no. 00430604046. Terminated |
KWS | None listed |
| Oct 7, 2005 | Zimmer Inc. Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 40 mm dia. articular surface, med, sterile, for cemented use only in the USA, Cat. no. 00430604640. Terminated |
KWS | None listed |
| Oct 7, 2005 | Zimmer Inc. Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 46 mm dia. articular surface, med, sterile, for cemented use only in the USA, Cat. no. 00430604600. Terminated |
KWS | None listed |
| Oct 7, 2005 | Zimmer Inc. Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 52 mm dia. articular surface, med, sterile, for cemented use only in the USA, Cat. no. 00430604652. Terminated |
KWS | None listed |
| Oct 7, 2005 | Zimmer Inc. Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 46 mm dia. articular surface, large, sterile, for cemented use only in the USA, Cat. no. 00430605246. Terminated |
KWS | None listed |
| Oct 7, 2005 | Zimmer Inc. Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 52 mm dia. articular surface, large, sterile, for cemented use only in the USA, Cat. no. 00430605200. Terminated |
KWS | None listed |
| Oct 7, 2005 | Zimmer Inc. Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 56 mm dia. articular surface, small, sterile, for cemented use only in the USA, Cat. no. 00430605256. Terminated |
KWS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.