FDA.reportPublic FDA data

TECOMET, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
21327321000306694TECOMET, INC.1N2026-01-015307 95th Ave KENOSHA WI US 53144
30052266643005226664Tecomet, Inc.1N2026-01-01301 Ballardvale St Wilmington MA US 01887
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
1454591677946758K955848ORTHOFIX MODULSYSTEMJDW1996-03-20
1454591878381897K954276STEALTHSTATIONHAW1996-01-24
1454591718432679K941048TRUE/LOK MONOLATERAL/BILATERAL FIXATORLXT1994-10-03
1454592027487892K895117HTO COMPRESSING STAPLEJDR1990-05-09
1454591109357128K141989MAKOPLASTY TOTAL HIP ALLPICATION, RIO STANDARD SYSTEMOLO2014-11-13
1454591028873910K133291ST360 DEGREES SPINAL FIXATION SYSTEMNKB2013-12-17
1454591082095700K133086TITLE 2 POLYAXIAL SPINAL SYSTEMNKB2013-11-27
1454591740602890K123486TRIATHLON TRITANIUM TIBIAL BASEPLATEMBH2013-05-03
1454591266110333K121732CANOPY LAMINOPLASTY FIXATION SYSTEMNQW2012-10-31
1454591139127015K121064MAKOPLASTY TOTAL HIP APPLICATION, RIO STANDARD SYSTEMOLO2012-06-06
1454591226907101K120906ZIMMER TRABECULAR METAL TOTAL ANKLEHSN2012-08-24
1454591662525225K120399LANX SPINAL FIXATION SYSTEMNKB2012-03-09
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
1454591230176675K081906PROTEX CT CERVICOTHORACIC SPINAL SYSTEMKWP2008-11-14
1454591132249595K070963REUNION HA FRACTURE STEMHSD2007-05-04
1454591175588497K070775MODIFICATION TO: PROVIDENCE ANTERIOR CERVICAL PLATE SYSTEMKWQ2007-04-19
1454591038682428K070561KMEDIC INTERNAL/EXTERNAL FIXATION DEVICESHTY2007-05-25
2070191705905942K070095TRIATHLON TS KNEE SYSTEMJWH2007-06-01
1454592071598147K060683ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEMKWP2006-04-18
1454591530687819K052069PROTEX STABILIZATION SYSTEM WITH ADDITIONAL COMPONENTESKWP2005-08-17
1454591666763956K050391PROTEX CT CERVICOTHORACIC SPINAL SYSTEMKWP2005-07-21
1454591021550208K042953MODIFICATION TO PROTEX STABILIZATION SYSTEMNKB2004-11-22
1454591013608603K040721ASSURE ANTERIOR CERVICAL PLATE SYSTEMKWQ2004-06-17
1454591168232390K040442PROTEX STABILIZATION SYSTEMMNH2004-05-20
1454591129025420K031217GMRS PRESS FIT STEMS WITH PUREFIX HALZO2003-05-23
1929981940867572K023675SYNTHES CERVIFIX/ AXONKWP2002-11-26
1454591135881034K023087GLOBAL MODULAR REPLACEMENT SYSTEM (GMRS)KRO2002-12-16
1454591094334226K012105POLYVAC SURGICAL INSTRUMENT DELIVERY SYSTEMKCT2002-08-02
1454591537818271K010361MEDTRONIC PS MEDICAL INVISX CRANIAL FIXATION SYSTEM, MODEL 60100-60900GXR2001-05-07
1929981906169886K001864SYNTHES CERVIFIX SYSTEMKWQ2000-07-20
1454591909437555
1454591930023688
1454591010691236
1454591034482677
1454591038690212
1454591040223588
1454591043594250
1454591065505187
1454591083777917
1454591088133648
1929981091281041
1454591096413897
1454591115884248
1929981137684997
1454591142834138
1454591174106026
1454591176636962
1454591193768676
1454591216114050
1454591232397336
1454591239238714
1454591256068756
1454591266530740
1929981285280139
1454591312464709
1454591336385012
1454591339602329
1454591352299251
1454591358065326
1454591381126227
1929981381683033
1454591422038725
1454591453078936
1454591457371366
1454591470881070
1454591476756548
1454591489041436
1454591491325926
1454591503103241
1454591527202604
1454591537121690
1454591559584348
1454591587878684
1454591627164238
1454591635629730
1454591652861668
1454591712814564
1454591716881409
1454591744176126
1454591748306190
1929981753965626
1454591777515827
1454591829394448
1929981839239238
1454591847653453
1454591850083118
1929981873905348
1454591877541039
1454591892876507
1929981906169886
1454591908256025
1929981916634535
1929981940867572
1454591943175400
1454591963526589
1454591980963794
1454591981429712
1454591990087666
1454591992697094
1454592037588909
1454592051844378

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NKB52013-12-17
KWP52008-11-14
KWQ32007-04-19
OLO22014-11-13
MBH12013-05-03
NQW12012-10-31
MJO 12012-09-28
LPH12012-09-14
KTT12012-09-04
HSN12012-08-24
JWH12007-06-01
HTY12007-05-25
HSD12007-05-04
MNH12004-05-20
LZO12003-05-23
KRO12002-12-16
KCT12002-08-02
GXR12001-05-07
JDW11996-03-20
HAW11996-01-24
LXT11994-10-03
JDR11990-05-09