XO1 Knee Balancing System— 510(k) K162237
Substantially EquivalentXpandortho, Inc.
FDA 510(k) clearance K162237 for XO1 Knee Balancing System, Substantially Equivalent on 2017-04-25. Applicant: Xpandortho, Inc.. Device class: 2.
Clearance details
- Applicant
- Xpandortho, 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
- La Jolla, CA, US
Recent devices under product code ONN
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