DeviceClearance

Product code MIX— Ear, Nose, Throat

CALCIUM HYDROXYLAPATITE VOCAL FOLD IMPLANT

Classification name
System, Vocal Cord Medialization
Device class
Class 2
Regulation
21 CFR 874.3620
Advisory panel
Ear, Nose, Throat
Total cleared
17
First cleared
Most recent

Market context for product code MIX

FDA has cleared 17 devices under product code MIX between 1997 and 2024, filed by 10 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code MIX

Recent clearances under product code MIX

Data sourced from openFDA. This site is unofficial and independent of the FDA.