Panels › Physical Medicine › Product code IQO · Class 1
Device, Prosthesis Alignment
Regulation 890.3025
0510(k)s in 12 months (0 all time)
0recalls in 12 months (2 all time)
0recalls that name a 510(k)
Top companies in IQO
| Company | 510(k)s | Recalls |
|---|---|---|
| Biomet U.K., Ltd. | 0 | 1 |
| Stryker Howmedica Osteonics Corp. | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 17, 2012 | Biomet U.K., Ltd. Oxford Gap Gauge SML 3/4mm.
The instrument is used for an intermediate check of the flexion and extension gaps when preparing the femur to accept the femoral component. Terminated |
IQO | None listed |
| Aug 26, 2009 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics PAL Pelvic Alignment Level, Ref: PAL 400; Howmedica Osteonics Corp, 325 Corporate Drive, Mahwah, NJ 07430.
Intended to determine proper anatomical orientation, selection, alignme Terminated |
IQO | None listed |
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