MIX · Class II · 21 CFR 874.3620

FDA Product Code MIX: System, Vocal Cord Medialization

Leading manufacturers include Smith & Nephew, Inc., Biomet, Inc. and Sofregen Medical, Inc..

17
Total
17
Cleared
111d
Avg days
1997
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared System, Vocal Cord Medialization Devices (Product Code MIX)

17 devices
1–17 of 17
Cleared May 03, 2024
Silk Voice (SMI-04)
K240919
Sofregen Medical
Ear, Nose, Throat · 30d
Cleared Nov 08, 2018
Silk Voice
K180631
Sofregen Medical, Inc.
Ear, Nose, Throat · 244d
Cleared Jun 26, 2001
LORENZ LACTOSORB VOCAL MEDIALIZATION IMPLANT
K011554
Biomet, Inc.
Ear, Nose, Throat · 39d
Cleared Jul 26, 2000
VOCOM SILICONE SYSTEM
K001466
Smith & Nephew, Inc.
Ear, Nose, Throat · 77d
Cleared Mar 01, 2000
VOCOM IMPLANT- 8MM
K000533
Smith & Nephew, Inc.
Ear, Nose, Throat · 13d

About Product Code MIX - Regulatory Context

510(k) Submission Activity

17 total 510(k) submissions under product code MIX since 1997, with 17 receiving FDA clearance (average review time: 111 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.