NEI · Class II · 21 CFR 872.4770

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

Leading manufacturers include Synthes (Usa), Walter Lorenz Surgical, Inc. and Stryker.

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 Apr 09, 2014
STRYKER TEMPORARY CONDYLAR PROSTHESIS
K133285
Stryker
Dental · 166d
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 Aug 06, 2001
ADD-ON CONDYLE
K002790
Walter Lorenz Surgical, Inc.
Dental · 333d
Cleared Jul 27, 2001
KLS-MARTIN TEMPORARY CONDYLAR IMPLANT
K990667
KLS-Martin L.P.
Dental · 878d
Cleared Oct 22, 1999
SYNTHES LOCKING RECONSTRUCTION PLATE (LRP) WITH CONDYLAR HEAD
K990637
Synthes (Usa)
Dental · 238d

About Product Code NEI - Regulatory Context