Home / 510(k) Clearances / K241269

510(k) K241269

mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO Total Prosthesis Kit by Med-El Elektromedizinische Geräte GmbH — Product Code ETA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 2025
Date Received
April 24, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Replacement, Ossicular Prosthesis, Total
Device Class
Class II
Regulation Number
874.3495
Review Panel
EN
Submission Type

Other clearances by Med-El Elektromedizinische Geräte GmbH

  • K241261 — mCLIP Partial Prosthesis, mCLIP ARC Partial Prosthesis, mXACT Partial Prosthesis (January 17, 2025)
  • K241142 — mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFI (January 17, 2025)

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  • K083780 — SUPERELELASTIC NITINOL PISTON, SUPERELASTIC NITINOL TRIMMABLE PISTON, MODEL SPL0 (March 23, 2009)
  • K043375 — FISCH TITANIUM MIDDLE EAR PROSTHESES (January 24, 2005)
  • K042503 — KURZ CLIP PISTON MVP, MODEL 1006 711-13/0.4 MM + 1006 761-63/0.6MM (October 1, 2004)
  • K030492 — TITANIUM OSSICULAR REPLACMENT SYSTEM (March 3, 2003)
  • K002378 — MODULAR PORP AND TORP MODEL TBD (August 29, 2000)
  • K001406 — HA/GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES (August 8, 2000)
  • K001404 — GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES, GO (August 8, 2000)
  • K001902 — BOJRAB UNIVERSAL LONG IMLANT, MODEL TBD (July 10, 2000)
  • K993583 — ZURICH TITANIUM OSSICULAR REPLACEMENT SYSTEM (November 10, 1999)