BARD CONTOUR LINK S.K.I. KNEE SYS— 510(k) K820002
Substantially EquivalentC.R. Bard, Inc.
FDA 510(k) clearance K820002 for BARD CONTOUR LINK S.K.I. KNEE SYS, Substantially Equivalent on 1982-05-27. Applicant: C.R. Bard, Inc.. Device class: 2.
Clearance details
- Applicant
- C.R. Bard, Inc.
- Product code
- Code HRY
- Device class
- Class 2
- Regulation
- 21 CFR 888.3530
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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Adverse events under product code HRY
product code HRY- Injury
- 1,551
- Malfunction
- 2,753
- Total
- 4,304
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.