PIVOT BIPOLAR FEMORAL HEAD— 510(k) K050966
Substantially EquivalentOrtho Development Corp.
FDA 510(k) clearance K050966 for PIVOT BIPOLAR FEMORAL HEAD, Substantially Equivalent on 2005-07-07. Applicant: Ortho Development Corp.. Device class: 2.
Clearance details
- Applicant
- Ortho Development Corp.
- Product code
- Code KWY
- Device class
- Class 2
- Regulation
- 21 CFR 888.3390
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Draper, UT, US
Recent devices under product code KWY
view allMore clearances from Ortho Development Corp.
view allAdverse events under product code KWY
product code KWY- Death
- 3
- Injury
- 2,049
- Total
- 2,052
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K050966
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K050966.
Data sourced from openFDA. This site is unofficial and independent of the FDA.