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mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO Total Prosthesis Kit

FDA 510(k) clearance K241269 · decided 2025-01-17

Clearance details

K-number
K241269
Device name
mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO Total Prosthesis Kit
Applicant
MED-EL Elektromedizinische Geräte GmbH
Decision
Substantially Equivalent
Date received
2024-04-24
Decision date
2025-01-17
Days to decision
268 days
Clearance type
Traditional
Product code
ETA
Device class
2
Regulation number
874.3495
Medical specialty
Ear, Nose, Throat
Advisory committee
Ear, Nose, Throat
Location
Innsbruck, AT
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.