ACCIN UNI-KNEE SYSTEM— 510(k) K060670
Substantially EquivalentAccin Corporation
FDA 510(k) clearance K060670 for ACCIN UNI-KNEE SYSTEM, Substantially Equivalent on 2006-06-02. Applicant: Accin Corporation. Device class: 2.
Clearance details
- Applicant
- Accin Corporation
- Product code
- Code HSX
- Device class
- Class 2
- Regulation
- 21 CFR 888.3520
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Clifton, NJ, US
Recent devices under product code HSX
view allMore clearances from Accin Corporation
view allAdverse events under product code HSX
product code HSX- Injury
- 1,003
- Other
- 1
- Total
- 1,004
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 K060670
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 K060670.
Data sourced from openFDA. This site is unofficial and independent of the FDA.