FDA.reportPublic FDA data

Temporary mandibular condyle prosthesis

Definition
A sterile implantable device intended for the temporary reconstruction of the mandibular condyle of the temporomandibular joint (TMJ) typically in a patient undergoing ablative surgery requiring the removal of the mandibular condyle. It is typically made of metal or synthetic material and includes the condyle head with an adjustable plate for attachment to the remaining natural mandible.
GUDID devices
25
Last updated
2021-11-30 15:37:43

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00888118131249LEVEL ONE CMFKLS-Martin L.P.50-174-04-612021-11-22
00888118131256LEVEL ONE CMFKLS-Martin L.P.50-174-04-912021-11-22
00888118131263LEVEL ONE CMFKLS-Martin L.P.50-174-04-092021-11-22
00888118131270LEVEL ONE CMF, STERILEKLS-Martin L.P.50-174-04-752021-11-22
00841036009830"""2.4MM"" LOCKING RECON SYSTEM"BIOMET MICROFIXATION, INC01-26912015-10-11
00841036009847"""2.4MM"" LOCKING RECON SYSTEM"BIOMET MICROFIXATION, INC01-26922015-10-11
00841036091507"""2.4MM"" LOCKING RECON SYSTEM"BIOMET MICROFIXATION, INC99-26932015-10-11
00888118073471LEVEL ONE CMFKLS-Martin L.P.50-173-01-092016-03-24
00888118073488LEVEL ONE CMFKLS-Martin L.P.50-173-02-092016-03-24
00888118073501LEVEL ONE CMFKLS-Martin L.P.50-173-03-912016-03-24
00888118073518LEVEL ONE CMFKLS-Martin L.P.50-174-01-092016-03-24
00888118073525LEVEL ONE CMF, STERILEKLS-Martin L.P.50-174-01-712016-03-23
00888118073532LEVEL ONE CMFKLS-Martin L.P.50-174-02-092016-03-24
00888118073549LEVEL ONE CMF, STERILEKLS-Martin L.P.50-174-02-712016-03-23
00888118073570LEVEL ONE CMFKLS-Martin L.P.50-174-03-912016-03-24
H980044490000NASYNTHES (U.S.A.) LP04.449.0002015-09-14
H980044490100NASYNTHES (U.S.A.) LP04.449.0102015-09-14
H980044490200NASYNTHES (U.S.A.) LP04.449.0202015-09-14
H980044490300NASYNTHES (U.S.A.) LP04.449.0302015-09-14
H980044490400NASYNTHES (U.S.A.) LP04.449.0402015-09-14
H980044970000NASYNTHES (U.S.A.) LP04.497.0002015-09-14
H980044970010MatrixMANDIBLESYNTHES (U.S.A.) LP04.497.0012015-09-14
10888118073492LEVEL ONE CMFKLS-Martin L.P.50-173-03-092016-03-24
10888118073553LEVEL ONE CMFKLS-Martin L.P.50-174-03-092016-03-24
10888118073560LEVEL ONE CMF, STERILEKLS-Martin L.P.50-174-03-752016-03-23