510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K905740Substantially Equivalent

Resorbable Bone Plug

Zimmer GmbH, Warsaw IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K905740 is the FDA 510(k) clearance record for RESORBABLE BONE PLUG, a class I device, cleared for Zimmer, Inc. on under FDA product code ESD (Hearing Aid, Air-Conduction, Prescription). FDA's definition for product code ESD reads: "An air-conduction hearing aid is a wearable sound amplifying device intended to compensate for impaired hearing that conducts sound to the ear through the air. This is a prescription hearing aid". FDA records list 872 510(k) clearances for Zimmer, Inc., from to . As of , FDA records show no recalls naming K905740.

Clearance record

Decision date
Received
(100 days to decision)
Product code
ESD Hearing Aid, Air-Conduction, Prescription
Regulation
21 CFR 874.3300
Device class
Class I
Review panel
Ear, Nose, Throat
Applicant
Zimmer, Inc. P.O. Box 708, Warsaw IN
Third party review
No

Clearances, product code ESD

Trailing 12 months

FDA records hold no clearances under product code ESD in the trailing twelve months.

FDA records show no clearances under product code ESD in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code ESD, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260