LOWER EXTREMITY EXTERNAL FIXATION - EXPANDED INDICATIONS— 510(k) K081244
Substantially EquivalentBiomet Trauma
FDA 510(k) clearance K081244 for LOWER EXTREMITY EXTERNAL FIXATION - EXPANDED INDICATIONS, Substantially Equivalent on 2008-07-30. Applicant: Biomet Trauma. Device class: 2.
Clearance details
- Applicant
- Biomet Trauma
- Product code
- Code KTT
- Device class
- Class 2
- Regulation
- 21 CFR 888.3030
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Warsaw, IN, US
Recent devices under product code KTT
view allMore clearances from Biomet Trauma
view allAdverse events under product code KTT
product code KTT- Death
- 11
- Injury
- 3,097
- Malfunction
- 1,261
- Total
- 4,369
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 K081244
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 K081244.
Data sourced from openFDA. This site is unofficial and independent of the FDA.