EZ-TRAX Stryker Mako Total Knee with Triathlon Containment Device— 510(k) K202270
Substantially EquivalentK1 Medical, LLC
FDA 510(k) clearance K202270 for EZ-TRAX Stryker Mako Total Knee with Triathlon Containment Device, Substantially Equivalent on 2020-12-02. Applicant: K1 Medical, LLC. Device class: 2.
Clearance details
- Applicant
- K1 Medical, LLC
- Product code
- Code KCT
- Device class
- Class 2
- Regulation
- 21 CFR 880.6850
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Woodbridge, CT, US
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