FDA.report

Tecomet Inc.

Matched from indexed company URL: TECOMET INC.

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
12256753001451451Tecomet Inc.1N2026-01-01115 Eames Street Wilmington MA US 01887

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1173641173556384K994070REVELATION POROUS HIP STEMLPH2000-01-20
1173641215012569K993289SMITH & NEPHEW COMPRESSION HIP SCREW SYSTEM, INTRAMEDULLARY HIP SCREW SYSTEMKTT1999-12-20
1173641417225165K974294ENCORE LINEAR POROUS COATED HIPLPH1998-01-12
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
1173641890455293K952970HOWMEDICA FEMORAL & PROXIMAL TIBIAL MODULAR REPLACEMENT SYTESMJDI1996-01-17
1173642067934241K952697TITANIUM CLASSIC COMPRESSION HIP SCREW SYSTEMHWC1995-09-12
1173641151128443K936127HOWMEDICA PREMIUM FEMORAL COMPONENTJDI1994-10-26
1173641891524678K936126HOWMEDICS DRG FEMORAL COMPONENTJDI1994-10-20
1173641939162945K932776CRUCIATE RETAINING CEMENTED TIBIAL COMPONENTSJWH1994-10-20
1173642044452072K895117HTO COMPRESSING STAPLEJDR1990-05-09
1173641921182865K823727SPECTRON PRIMARY STEM FEMORAL PROSTHESJDI1983-03-08
1173641327784891K163585Responsive Orthopedics Total Hip Arthroplasty SystemLZO2017-06-02
1173641751650299K150121Zimmer Periarticular Plating SystemHRS2015-02-23
1173641615838272K142579Zimmer Periarticular Plating SystemHRS2014-10-22
1173641118909865K141734ZIMMER PERIARTICULAR LOCKING SYSTEMHRS2014-08-13
1173641494682838K141331BIOMET ORTHOPAEDIC SALVAGE SYSTEM (OSS)JDI2014-10-27
1173641541219411K132626PIPELINE TOTAL HIP SYSTEM (LINE EXTENSION)LPH2013-09-19
1173641081262770K122158PBP TOTAL HIP SYSTEMOQG2012-12-11
1173641769698544K121940LANX SPINAL FIXATION SYSTEMNKB2012-08-02
1173641642406917K121627SMITH & NEPHEW REDAPT REVISION FEMORAL SYSTEMMEH2012-10-15
1173641129686904K121443JOURNEY II CR KNEE SYSTEMJWH2012-08-13
1173642011048328K120399LANX SPINAL FIXATION SYSTEMNKB2012-03-09
1173641851889124K120359ORTHOLOC 3DI HALLUX SYSTEMHRS2012-05-03
1173641475000218K113789MODULAR PROXIMALLY FLUTED HIP STEMMEH2012-04-19
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
1173641274463124K111272RHAUSLER PLAGE ANTERIOR CERVICAL FUSION SYSTEMOVE2011-11-29
1173641093700569K111039ZIMMER PERIARTICULAR LOCKING PLATE SYSTEMHRS2011-05-19
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
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
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
1173641669812009K070963REUNION HA FRACTURE STEMHSD2007-05-04
1173641324764774K061569SMITH & NEPHEW COMPETITOR DEUCE FEMORAL COMPONENTSNPJ2006-07-06
1173641192560526K060635CONSENSUS ACETABULAR SHELL SYSTEMLPH2006-04-28
1173641273688142K052792ANTHOLOGY HIP STEMJDI2005-10-07
1173641271250525K052265SMITH & NEPHEW COMPETITOR DUO KNEE FEMORALNPJ2005-12-27
1173642062588826K051747SBI WRISTFITHRS2005-09-06
1173641788707666K051086SMITH & NEPHEW PATELLO-FEMORAL IMPLANTKRR2005-05-31
1173641158913965K050138MODIFICATION TO: RESTORATION MODULAR SYSTEMJDI2005-03-21
1173641672350656K043440SMITH & NEPHEW, INC. REVISION KNEE SYSTEMJWH2005-02-18
1173641338299203K042515SMITH & NEPHEW, INC. HIGH PERFORMANCE KNEEJWH2005-03-14
1173641331537395K040749MODULAR REPLACEMENT SYSTEM CEMENTED STEMSKRO2004-06-17
1173641270427000K040128MODIFICATION TO MODULAR REPLACEMENT SYSTEM (MRS) HUMERAL STEMSHSD2004-03-26
1173642061979718K033669SMITH & NEPHEW LOCKING BONE PLATE SYSTEM (LOCKING BONE PLATES AND SCREWS)HRS2003-12-10
1173642067476679K031217GMRS PRESS FIT STEMS WITH PUREFIX HALZO2003-05-23
1173641895312029K030301UNICONDYLAR FEMORAL COMPONENTJWH2003-02-25
1173642046924700K030236ACUMATCH P-SERIES POROUS PRESS-FIT FEMORAL COMPONENTLPH2003-02-20
1173641163635639K023087GLOBAL MODULAR REPLACEMENT SYSTEM (GMRS)KRO2002-12-16
1173641244302918K022549RESTORATION MODULAR SYSTEMLZO2002-09-23
1173641695989812K002141ACUMATCH P-SERIES PRESS-FIT PLASMA, ACUMATCH P-SERIES PRESS-FIT, ACUMATCH L-SERIES PRESS-FITLWJ2000-08-16
11736410179248871969-12-31
11736410179248871969-12-31
11736410179248871969-12-31
11736410179248871969-12-31
11736415515608861969-12-31
11736415515608861969-12-31
11736415515608861969-12-31
11736415515608861969-12-31
1173641331537395
1173641399508784
1173641788877250
1173642045841694

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
HRS92015-02-23
JDI92014-10-27
LPH82013-09-19
JWH72012-08-13
LZO42017-06-02
MEH32012-10-15
HSX32012-01-05
KRO32008-07-23
NKB22012-08-02
HSD22007-05-04
NPJ22006-07-06
OQG12012-12-11
HSB12012-04-02
OVE12011-11-29
OVD12011-02-10
PHX12010-08-02
KWQ12009-04-07
KWA12009-03-06
KWS12008-03-28
KRR12005-05-31
LWJ12000-08-16
KTT11999-12-20
JDG11996-08-08
HWC11995-09-12
JDR11990-05-09

PMA

PMN

Applications

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