TrueBalance Surgical System— 510(k) K220830
Substantially EquivalentThese Three Medical, LLC
FDA 510(k) clearance K220830 for TrueBalance Surgical System, Substantially Equivalent on 2022-09-15. Applicant: These Three Medical, LLC. Device class: 2.
Clearance details
- Applicant
- These Three Medical, LLC
- 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
- Phoenix, AZ, US
Recent devices under product code ONN
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