NEI · Class II · 21 CFR 872.4770

FDA Product Code NEI: Prosthesis, Condyle, Mandibular, Temporary

Leading manufacturers include Synthes (Usa).

7
Total
7
Cleared
310d
Avg days
1999
Since

FDA 510(k) Cleared Prosthesis, Condyle, Mandibular, Temporary Devices (Product Code NEI)

7 devices
1–7 of 7
Cleared Sep 05, 2008
MODIFICATION TO SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM
K081747
Synthes (Usa)
Dental · 78d
Cleared Jan 05, 2007
SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM
K063181
Synthes (Usa)
Dental · 78d
Cleared Oct 22, 1999
SYNTHES LOCKING RECONSTRUCTION PLATE (LRP) WITH CONDYLAR HEAD
K990637
Synthes (Usa)
Dental · 238d

About Product Code NEI - Regulatory Context