VERASENSE for Exactech Equinoxe Size 38 mm, VERASENSE for Exactech Equinoxe Size 42 mm, LinkStation MINI, LinkStation MINI Evaluation Kit, VERASENSE Software Application for Shoulder— 510(k) K200587
Substantially EquivalentOrthosensor, Inc.
FDA 510(k) clearance K200587 for VERASENSE for Exactech Equinoxe Size 38 mm, VERASENSE for Exactech Equinoxe Size 42 mm, LinkStation MINI, LinkStation MINI Evaluation Kit, VERASENSE Software Application for Shoulder, Substantially Equivalent on 2020-08-25. 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
- Traditional
- Location
- Dania Beach, FL, US
Recent devices under product code ONN
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Data sourced from openFDA. This site is unofficial and independent of the FDA.