EXPANDABLE KNEE— 510(k) K020381
Substantially EquivalentBiomet Orthopedics, Inc.
FDA 510(k) clearance K020381 for EXPANDABLE KNEE, Substantially Equivalent on 2002-05-06. Applicant: Biomet Orthopedics, Inc.. Device class: 2.
Clearance details
- Applicant
- Biomet Orthopedics, Inc.
- Product code
- Code KRO
- Device class
- Class 2
- Regulation
- 21 CFR 888.3510
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Warsaw, IN, US
Recent devices under product code KRO
view allMore clearances from Biomet Orthopedics, Inc.
view allAdverse events under product code KRO
product code KRO- Death
- 19
- Injury
- 4,841
- Total
- 4,860
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 K020381
K-number listed on FDA's recall record- Z-0304-2018 — RED SEXP DSTL FEM 19CM RT ASSY, model # CP111817
- Z-0305-2018 — RED SEXP DSTL FEM 19CM LT ASSY, model # CP111828
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K020381.
Data sourced from openFDA. This site is unofficial and independent of the FDA.