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Replacement, Ossicular Prosthesis, Total

FDA product code ETA · 39 cleared devices

Class 2 Ear, Nose, Throat
Regulation
21 CFR 874.3495
Review panel
EN
Implant
Yes
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
1976-10-05 – 2026-04-03
ETA 2026-04-03

mGRIP Total Prosthesis (3.00 mm) (58689); mGRIP Total Prosthesis (3.25 mm) (58691); mGRIP Total Prosthesis (3.50 mm) (58693); mGRIP Total Prosthesis (3.75 mm) (58695); mGRIP Total Prosthesis (4.00 mm) (58697); mGRIP Total Prosthesis (4.25 mm) (58699); mGRIP Total Prosthesis (4.50 mm) (58701); mGRIP Total Prosthesis (4.75 mm) (58703); mGRIP Total Prosthesis (5.00 mm) (58705); mGRIP Total Prosthesis (5.50 mm) (58707); mGRIP Total Prosthesis (6.00 mm) (58709); mGRIP Total Prosthesis (6.50

Applicant MED-EL Elektromedizinische Geräte GmbH

K number K260719

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