FDA.reportPublic FDA data

TECOMET

Matched from indexed company URL: Tecomet

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
12256753001451451Tecomet Inc.1N2026-01-01115 Eames Street Wilmington MA US 01887
12264253003018882TECOMET1N2026-01-01170 New Boston Street Woburn MA US 01801
21327321000306694TECOMET, INC.1N2026-01-015307 95th Ave KENOSHA WI US 53144
30052266643005226664Tecomet, Inc.1N2026-01-01301 Ballardvale St Wilmington MA US 01887
30071379283007137928Tecomet Boulder1N2020-04-256165 Lookout Road Boulder CO US 80301
30135011693013501169Tecomet, Inc.1N2020-04-25201 Route 59, Bldg E Hillburn NY US 10931

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1454592049546970P100003SECURE-C ARTIFICIAL CERVICAL DISCMJO2012-09-28
1173641173556384K994070REVELATION POROUS HIP STEMLPH2000-01-20
1173641215012569K993289SMITH & NEPHEW COMPRESSION HIP SCREW SYSTEM, INTRAMEDULLARY HIP SCREW SYSTEMKTT1999-12-20
1499701693965632K990214FLUORONAV MODULE FOR THE STEALTHSTATION SYSTEMHAW1999-04-22
1128461316849565K980199SYNTHES 1.5MM/2.0MM ORTHOGNATHIC MAXILLARY PLATES AND SCREWSDZL1998-04-17
1173641417225165K974294ENCORE LINEAR POROUS COATED HIPLPH1998-01-12
1499701962043837K974161STEALTHSTATION SYSTEMHAW1997-11-21
1173641111039158K973685REVELATION POROUS HIP STEMLPH1997-12-19
1173641985479604K970351GLOBAL TAPER SPECTRON HIP STEMSJDI1997-02-28
1173641098797331K970200RELIANCE PF FEMORAL STEMSLZO1997-04-09
1173642021182988K962557GENESIS II ZIRCONIUM FEMORAL COMPONENT/PROFIX ZIRCONIUM FEMORAL COMPONENTJWH1996-12-05
1173642056715199K962002AURA HIP SYSTEM CALCAR REPLACEMENT FEMORAL STEMJDG1996-08-08
1173641332610452K961304AURA HIP SYSTEM CEMENTED FEMORAL STEM/CEMENTED LONG FEMORAL STEMJDI1996-10-01
1454591677946758K955848ORTHOFIX MODULSYSTEMJDW1996-03-20
1454591878381897K954276STEALTHSTATIONHAW1996-01-24
1173641890455293K952970HOWMEDICA FEMORAL & PROXIMAL TIBIAL MODULAR REPLACEMENT SYTESMJDI1996-01-17
1173642067934241K952697TITANIUM CLASSIC COMPRESSION HIP SCREW SYSTEMHWC1995-09-12
1454591718432679K941048TRUE/LOK MONOLATERAL/BILATERAL FIXATORLXT1994-10-03
1173641151128443K936127HOWMEDICA PREMIUM FEMORAL COMPONENTJDI1994-10-26
1173641891524678K936126HOWMEDICS DRG FEMORAL COMPONENTJDI1994-10-20
1173641939162945K932776CRUCIATE RETAINING CEMENTED TIBIAL COMPONENTSJWH1994-10-20
1128461431532588K923802TIMESH TITANIUM MINI-SOFTPLATE/SCREWJEY1992-10-26
1128461896768866K923419TISMESH SYSTEMJEY1993-04-08
1128462069789929K922308TILGHMAN TITANIUM MESH SKELETAL ORBIT LINERFTM1993-01-12
1454592027487892K895117HTO COMPRESSING STAPLEJDR1990-05-09
1173642044452072K895117HTO COMPRESSING STAPLEJDR1990-05-09
1173641921182865K823727SPECTRON PRIMARY STEM FEMORAL PROSTHESJDI1983-03-08
1128461612466811K173767A. L. P. S. Clavicle Plating SystemHRS2018-04-06
1499701632008120K172849Intellijoint HIP System (Cart), Intellijoint HIP System (Portable), Intellijoint HIP Instrument TrayOLO2017-11-16
1173641327784891K163585Responsive Orthopedics Total Hip Arthroplasty SystemLZO2017-06-02
1128461475089575K153400ProLift Expandable SystemMAX2016-03-07
1128461009451737K152282Cam Lock Plating SystemKWQ2015-11-20
1499701651919325K151364Intellijoint HIP(tm) SystemOLO2015-12-28
1173641751650299K150121Zimmer Periarticular Plating SystemHRS2015-02-23
1173641615838272K142579Zimmer Periarticular Plating SystemHRS2014-10-22
1128461244383786K142253SOLSTICE OCT SystemKWP2015-04-23
1454591109357128K141989MAKOPLASTY TOTAL HIP ALLPICATION, RIO STANDARD SYSTEMOLO2014-11-13
1173641118909865K141734ZIMMER PERIARTICULAR LOCKING SYSTEMHRS2014-08-13
1173641494682838K141331BIOMET ORTHOPAEDIC SALVAGE SYSTEM (OSS)JDI2014-10-27
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
1454591028873910K133291ST360 DEGREES SPINAL FIXATION SYSTEMNKB2013-12-17
1454591082095700K133086TITLE 2 POLYAXIAL SPINAL SYSTEMNKB2013-11-27
1173641541219411K132626PIPELINE TOTAL HIP SYSTEM (LINE EXTENSION)LPH2013-09-19
1128461288860811K131480EMERGE MEDICAL LOCKING ONE-THIRD TUBULAR PLATE SYSTEMHRS2013-07-03
1499701753807978K131425NAVIGATED CAPSTONE TRIALS, CLYDESDALE TRIALS, CAPSTONE & CLYDESDALE INSERTEROLO2013-08-14
1128461521859032K130202IRIS ANTERIOR CERVICAL PLATEKWQ2013-04-29
1499701677297840K124004NAVIGATED CD HORIZON SOLERA SCREWDRIVERS, TAPS, ILIAC TAPS, LEGACY TAPSOLO2013-03-22
1128461962396625K123723SYNTHES MATRIXNEURO CRANIAL PLATING SYSTEMGWO2013-09-05
1454591740602890K123486TRIATHLON TRITANIUM TIBIAL BASEPLATEMBH2013-05-03
1128461056851234K122382DYNASTY BIOFOAM SHELLMBL2012-10-22
1173641081262770K122158PBP TOTAL HIP SYSTEMOQG2012-12-11
1173641769698544K121940LANX SPINAL FIXATION SYSTEMNKB2012-08-02
1454591266110333K121732CANOPY LAMINOPLASTY FIXATION SYSTEMNQW2012-10-31
1173641642406917K121627SMITH & NEPHEW REDAPT REVISION FEMORAL SYSTEMMEH2012-10-15
1173641129686904K121443JOURNEY II CR KNEE SYSTEMJWH2012-08-13
1454591139127015K121064MAKOPLASTY TOTAL HIP APPLICATION, RIO STANDARD SYSTEMOLO2012-06-06
1454591226907101K120906ZIMMER TRABECULAR METAL TOTAL ANKLEHSN2012-08-24
1454591662525225K120399LANX SPINAL FIXATION SYSTEMNKB2012-03-09
1173642011048328K120399LANX SPINAL FIXATION SYSTEMNKB2012-03-09
1173641851889124K120359ORTHOLOC 3DI HALLUX SYSTEMHRS2012-05-03
1173641475000218K113789MODULAR PROXIMALLY FLUTED HIP STEMMEH2012-04-19
1454591817303460K113770ORTHOFIX GALAXY FIXATION SYSTEMKTT2012-09-04
1454591225725789K113434LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS)NKB2011-12-19
1454591702462077K113296ZMR HIP SYSTEM KWZ-PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMERLPH2012-09-14
1173641322220662K113038SMITH & NEPHEW INC. UNICOMPARTMENTAL AND BIOCOMPARTMENTAL KNEE SYSTEM INSTRUMENTSHSX2012-01-05
1173641222299413K112982ANATOMIC ANKLE ARTHRODESIS INTERLOCKING NAIL(A3 INTERLOCKING NAIL )HSB2012-04-02
1173641964900600K112941LEGION NARROW OXINIUM CRUCIATE RETAINING AND POSTERIOR STABILIZED FENORAL COMPONENTSJWH2011-12-20
1128461459780106K111953NAUTILUS SPINAL SYSTEMNKB2012-08-07
1128461759719895K111834DISCO SUBTALAR IMPLANTHWC2011-12-06
1173641274463124K111272RHAUSLER PLAGE ANTERIOR CERVICAL FUSION SYSTEMOVE2011-11-29
1173641093700569K111039ZIMMER PERIARTICULAR LOCKING PLATE SYSTEMHRS2011-05-19
1128461446527950K110029CONSERVE BIO FOAM SHELLKWA2011-04-19
1128461701775638K103183TRILLIANT SURGICAL SUBTALAR IMPLANTHWC2011-02-08
1173641059274867K102738LANX FUSION SYSTEMOVD2011-02-10
1173641156800966K100933CONSENSUS CS2 PLUS ACETABULAR INSERTLPH2010-10-06
1173641174048549K100741REVERSE SHOULDER PROSTHESIS MONOBLOCK STEM, REVERSE SHOULDER PROSTHESIS HUMERAL INSERTS, MODEL 510-00-006/012PHX2010-08-02
1128461783994982K093200LIFE SPINE LUMBAR PLATE SYSTEMKWQ2010-01-19
1128461440423923K090320CONQUEST SPINAL SYSTEMNKB2009-07-22
1173641769882783K090316MODIFICATION TO: LANX ANTERIOR CERVICAL PLATE SYSTEMKWQ2009-04-07
1173641203002754K083213SYNTHES 2.7 MM/3.5 MM LCP DISTAL FIBULA PLATESHRS2008-12-30
1173641808151899K082924DYNASTY POROUS ACETABULAR SHELL, DYNASTY POLYETHYLENE ACETABULAR LINER, DYNASTY METAL ACETABULAR LINERKWA2009-03-06
1454591230176675K081906PROTEX CT CERVICOTHORACIC SPINAL SYSTEMKWP2008-11-14
1173641568314830K081351MODIFICATION TO JOURNEY UNICONDYLAR FEMORAL IMPLANTHSX2008-07-24
1173641193743791K081124MDF REVISION HIP SYSTEMMEH2008-07-31
1173641043264839K081111LEGION HINGE KNEE SYSTEMKRO2008-07-23
1173641340850272K080625SMITH & NEPHEW MIS HIP STEM WITH STIKTITELPH2008-05-08
1173641767900259K080402ENCORE SHOULDER PRIMARY HUMERAL STEM, MODEL 500-00, ENCORE SHOULDER HUMERAL HEAD, MODEL 520-38KWS2008-03-28
1173641990393002K073460SYNTHES 2.7 MM/3.5 MM LCP DISTAL FIBULA PLATESHRS2008-02-21
1173641577607569K073175JOURNEY UNICONDYLAR FEMORAL IMPLANTHSX2007-12-20
1454591132249595K070963REUNION HA FRACTURE STEMHSD2007-05-04
1173641669812009K070963REUNION HA FRACTURE STEMHSD2007-05-04
1454591175588497K070775MODIFICATION TO: PROVIDENCE ANTERIOR CERVICAL PLATE SYSTEMKWQ2007-04-19
1454591038682428K070561KMEDIC INTERNAL/EXTERNAL FIXATION DEVICESHTY2007-05-25
1128461914751171K070285LIFE SPINE ANTERIOR CERVICAL PLATE SYSTEMKWQ2007-03-13
2070191705905942K070095TRIATHLON TS KNEE SYSTEMJWH2007-06-01
1173641324764774K061569SMITH & NEPHEW COMPETITOR DEUCE FEMORAL COMPONENTSNPJ2006-07-06
1454592071598147K060683ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEMKWP2006-04-18
1173641192560526K060635CONSENSUS ACETABULAR SHELL SYSTEMLPH2006-04-28
1173641273688142K052792ANTHOLOGY HIP STEMJDI2005-10-07
1173641271250525K052265SMITH & NEPHEW COMPETITOR DUO KNEE FEMORALNPJ2005-12-27
1454591530687819K052069PROTEX STABILIZATION SYSTEM WITH ADDITIONAL COMPONENTESKWP2005-08-17
1173642062588826K051747SBI WRISTFITHRS2005-09-06
1173641788707666K051086SMITH & NEPHEW PATELLO-FEMORAL IMPLANTKRR2005-05-31
1499701451773421K050438STEALTHSTATION SYSTEM UPDATEHAW2005-06-02
1454591666763956K050391PROTEX CT CERVICOTHORACIC SPINAL SYSTEMKWP2005-07-21
1173641158913965K050138MODIFICATION TO: RESTORATION MODULAR SYSTEMJDI2005-03-21
1173641672350656K043440SMITH & NEPHEW, INC. REVISION KNEE SYSTEMJWH2005-02-18
1454591021550208K042953MODIFICATION TO PROTEX STABILIZATION SYSTEMNKB2004-11-22
1173641338299203K042515SMITH & NEPHEW, INC. HIGH PERFORMANCE KNEEJWH2005-03-14
1173641331537395K040749MODULAR REPLACEMENT SYSTEM CEMENTED STEMSKRO2004-06-17
1454591013608603K040721ASSURE ANTERIOR CERVICAL PLATE SYSTEMKWQ2004-06-17
1454591168232390K040442PROTEX STABILIZATION SYSTEMMNH2004-05-20
1173641270427000K040128MODIFICATION TO MODULAR REPLACEMENT SYSTEM (MRS) HUMERAL STEMSHSD2004-03-26
1173642061979718K033669SMITH & NEPHEW LOCKING BONE PLATE SYSTEM (LOCKING BONE PLATES AND SCREWS)HRS2003-12-10
1454591129025420K031217GMRS PRESS FIT STEMS WITH PUREFIX HALZO2003-05-23
1173642067476679K031217GMRS PRESS FIT STEMS WITH PUREFIX HALZO2003-05-23
1173641895312029K030301UNICONDYLAR FEMORAL COMPONENTJWH2003-02-25
1173642046924700K030236ACUMATCH P-SERIES POROUS PRESS-FIT FEMORAL COMPONENTLPH2003-02-20

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HRS142018-04-06
JDI92014-10-27
NKB92013-12-17
LPH92013-09-19
KWQ82015-11-20
JWH82012-08-13
OLO62017-11-16
KWP62015-04-23
LZO52017-06-02
KRO42008-07-23
HAW42005-06-02
MEH32012-10-15
HSX32012-01-05
HWC32011-12-06
HSD32007-05-04
KTT22012-09-04
KWA22011-04-19
NPJ22006-07-06
JEY21993-04-08
JDR21990-05-09
MAX12016-03-07
GWO12013-09-05
MBH12013-05-03
OQG12012-12-11
NQW12012-10-31
MBL12012-10-22
MJO 12012-09-28
HSN12012-08-24
HSB12012-04-02
OVE12011-11-29
OVD12011-02-10
PHX12010-08-02
KWS12008-03-28
HTY12007-05-25
KRR12005-05-31
MNH12004-05-20
KCT12002-08-02
GXR12001-05-07
LWJ12000-08-16
DZL11998-04-17

GUDID#

147 records. Showing 1-40. Next