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TECOMET

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
12264253003018882TECOMET1N2026-01-01170 New Boston Street Woburn MA US 01801

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1128461316849565K980199SYNTHES 1.5MM/2.0MM ORTHOGNATHIC MAXILLARY PLATES AND SCREWSDZL1998-04-17
1128461431532588K923802TIMESH TITANIUM MINI-SOFTPLATE/SCREWJEY1992-10-26
1128461896768866K923419TISMESH SYSTEMJEY1993-04-08
1128462069789929K922308TILGHMAN TITANIUM MESH SKELETAL ORBIT LINERFTM1993-01-12
1128461612466811K173767A. L. P. S. Clavicle Plating SystemHRS2018-04-06
1128461475089575K153400ProLift Expandable SystemMAX2016-03-07
1128461009451737K152282Cam Lock Plating SystemKWQ2015-11-20
1128461244383786K142253SOLSTICE OCT SystemKWP2015-04-23
1128461068707139K133541EMERGE MEDICAL SMALL AND LARGE NON-LOCKING FRAGMENT PLATE SYSTEMHRS2014-01-28
1128461217483562K133536EMERGE MEDICAL BONE PLATE SYSTEMHRS2014-02-26
1128461546215512K133452EMERGE MEDICAL SMALL FRAGMENT LOCKED PLATING SYSTEMHRS2014-01-08
1128461288860811K131480EMERGE MEDICAL LOCKING ONE-THIRD TUBULAR PLATE SYSTEMHRS2013-07-03
1128461521859032K130202IRIS ANTERIOR CERVICAL PLATEKWQ2013-04-29
1128461962396625K123723SYNTHES MATRIXNEURO CRANIAL PLATING SYSTEMGWO2013-09-05
1128461056851234K122382DYNASTY BIOFOAM SHELLMBL2012-10-22
1128461459780106K111953NAUTILUS SPINAL SYSTEMNKB2012-08-07
1128461759719895K111834DISCO SUBTALAR IMPLANTHWC2011-12-06
1128461446527950K110029CONSERVE BIO FOAM SHELLKWA2011-04-19
1128461701775638K103183TRILLIANT SURGICAL SUBTALAR IMPLANTHWC2011-02-08
1128461783994982K093200LIFE SPINE LUMBAR PLATE SYSTEMKWQ2010-01-19
1128461440423923K090320CONQUEST SPINAL SYSTEMNKB2009-07-22
1128461914751171K070285LIFE SPINE ANTERIOR CERVICAL PLATE SYSTEMKWQ2007-03-13
1128461026405740
1128461129469017
1128461309137974
1128461316849565
1128461407453007
1128461414674136
1128461456717370
1128461567633729
1128461568357930
1128461599243886
1128461612466811
1128461721598132
1128461735083778
1128461739549103
1128461796196872
1128461824448109
1128462012481931
1128462049433244
1128462072687085

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HRS52018-04-06
KWQ42015-11-20
NKB22012-08-07
HWC22011-12-06
JEY21993-04-08
MAX12016-03-07
KWP12015-04-23
GWO12013-09-05
MBL12012-10-22
KWA12011-04-19
DZL11998-04-17
FTM11993-01-12

GUDID#

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