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FDA Product Code

FDA Product Code NEI — Clearance Directory

Device Class
Class II
Assigned Panel
Dental
21 CFR Citation
872.4770

510(k) Clearances — 7 records

K-Number Device Name Applicant Decision Date Clearance Type Summary
K133285 STRYKER TEMPORARY CONDYLAR PROSTHESIS Stryker 2014-04-09 Traditional PDF ↗
K081747 MODIFICATION TO SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM Synthes (Usa) 2008-09-05 Traditional PDF ↗
K063181 SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM Synthes (Usa) 2007-01-05 Traditional PDF ↗
K031701 OSTEOMED TEMPORARY CONDYLAR ATTACHMENT SYSTEM Osteomed LP 2004-07-08 Traditional PDF ↗
K002790 ADD-ON CONDYLE Walter Lorenz Surgical, Inc. 2001-08-06 Traditional PDF ↗
K990667 KLS-MARTIN TEMPORARY CONDYLAR IMPLANT KLS-Martin L.P. 2001-07-27 Traditional PDF ↗
K990637 SYNTHES LOCKING RECONSTRUCTION PLATE (LRP) WITH CONDYLAR HEAD Synthes (Usa) 1999-10-22 Traditional PDF ↗

Product code NEI · Class II · Dental. Data: openFDA.