ORTHOSENSOR KNEE BALANCER— 510(k) K130380
Substantially EquivalentOrthosensor, Inc.
FDA 510(k) clearance K130380 for ORTHOSENSOR KNEE BALANCER, Substantially Equivalent on 2013-06-13. Applicant: Orthosensor, Inc.. Device class: 2.
Clearance details
- Applicant
- Orthosensor, Inc.
- Product code
- Code ONN
- Device class
- Class 2
- Regulation
- 21 CFR 882.4560
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Sunrise, FL, US
Recent devices under product code ONN
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- K150372 — VERASENSE Knee System
Recalls naming K130380
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 K130380.
Data sourced from openFDA. This site is unofficial and independent of the FDA.