510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K080363Substantially Equivalent

Baha Cordelle II

Cochlear Bone Anchored Systems AB, Englewood CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K080363 is the FDA 510(k) clearance record for BAHA CORDELLE II, a class II device, cleared for Cochlear Bone Anchored Systems AB on under FDA product code MAH (Hearing Aid, Bone Conduction, Implanted). FDA records list 2 510(k) clearances for Cochlear Bone Anchored Systems AB, from to . As of , FDA records show no recalls naming K080363.

Clearance record

Decision date
Received
(59 days to decision)
Product code
MAH Hearing Aid, Bone Conduction, Implanted
Regulation
21 CFR 874.3302
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Cochlear Bone Anchored Systems AB 400 Inverness Pkwy., Englewood CO
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MAH

Trailing 12 months
1 clearance under product code MAH in the twelve months to October 2026, August 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MAH, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260