FDA.reportPublic FDA data

Lincotek Medical

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30084217303008421730Lincotek Medical1N2026-01-013110 Stage Post Dr Ste 117 Bartlett TN US 38133
30040868723004086872Lincotek Medical1N2020-04-25867 W. 400 N. Logan UT US 84321

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
781481357715815K9316656.5 MM CANCELLOUS BONE SCREWHWC1994-02-17
781481405095959K181397DualXMAX2018-09-27
781481126293954K181115CxHA PEEK Cervical IBF SystemODP2018-07-16
781481134531795K181063Kestrel™ Buttress Plate SystemKWQ2018-07-13
781482001465693K171004Hintermann Series H2 Total Ankle SystemHSN2017-11-07
781481489618174K161755Integrity-SI TM Fusion SystemOUR2016-12-14
781481001539258K161081SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemOVE2016-09-14
781481670613270K152000SMV Scientific Bone Plate and Screw SystemHRS2015-11-25
781481357166702K151459Integra Total Ankle Replacement SystemHSN2015-08-31
781481342781778K142066AERO-LL LUMBAR CAGE SYSTEMOVD2014-11-13
781481184181530K140463INTEGRA EXTERNAL FIXATION SYSTEMKTT2014-10-10
781481461219193K140238EXCELLA III-D SPINAL DEFORMITY SYSTEMNKB2014-05-07
781481813192579K133328AERO-AL LUMBAR CAGE SYSTEMOVD2014-05-30
781481893418243K132884PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEMNKB2013-11-25
781481685157729K132735AXIA RADIAL HEAD SYSTEMKWI2014-01-07
781481336541545K131980SEQUOIA PEDICLE SCREW SYSTEM INCLUDING SPEEDLINK II TRANSVERSE CONNECTOR SYSTEMNKB2013-09-04
781481495607207K123207PRIMALIF TM LLIF UNITARY PEEK LATERAL LUMBAR INTERBODY FUSION SYSTEMMAX2012-11-29
781481900510915K122571MALIBU SPINAL SYSTEM WITH THE DAYTONA DEFORMITY SYSTEMNKB2012-12-12
781481174136591K103837BALANCED KNEE SYSTEM REVISION OFFSET TIBIAJWH2011-03-24
781481572897268K102248EXCELLA II SPINAL SYSTEM MODEL EC2-00NKB2010-10-07
781481785199845K102026SEASPINE SPACER SYSTEMMAX2011-05-12
781481926795772K100845PATHFINDER II, MINIMALLY INVASIE PEDICLE SCREW SYSTEM MODEL 3500 SERIESNKB2010-09-21
781481327446462K100354PRIMAL OK INTERSPINOUS FUSION SYSTEMKWP2010-08-17
781481841545201K091614OSTEOMED FOOT PLATING SYSTEMHRS2009-09-10
781481582957745K083089NEWPORT SPINAL SYSTEMNKB2009-01-13
781481621254940K082310HOLLYWOOD, PACIFICA, REDONDO, VENTURAMAX2008-11-10
781481475428332K082309CAMBRIAODP2009-04-09
781481755714387K081331FIXXSURE CROSS LINKMNH2008-07-23
781481800173573K080526SIERRA SYSTEMKWP2008-04-16
781481510053116K072729SIERRAKWP2008-04-17
781481764977641K072605MALIBU SPINAL SYSTEMNKB2007-12-20
781481736766386K062934SIERRAMNI2006-11-16
781481038443231K051942MALIBU SPINAL SYSTEMKWP2005-07-27
781481975438895K051663MALIBU SPINAL SYSTEMNKB2005-07-12
781481411703455K051075ENCORE REVERSE SHOULDER PROSTHESISPHX2005-05-27
781481867150012K043232UCR SPINAL SYSTEMNKB2004-12-21
781482068561718K041066ENCORE REVERSE SHOULDER PROSTHESISPHX2005-03-24
781481308623695K032368SONOMA ANTERIOR CERVICAL PLATE SYSTEMKWQ2003-10-09
781481676817483K031201ORTHO DEVELOPMENT BALANCED KNEE MODULAR TIBIAL SYSTEMJWH2003-07-15
781481563165967H980002
781481023615876
781481060458814
781481078877727
781481158835958
781481252891749
781481263484454
781481271523131
781481305237308
781481321126129
781481334718993
781481430052961
781481432405361
781481490136909
781481590014100
781481846633641
781481933780139
781482062546037
1896841093045955
1896841136952931
1896841152702433
1896841246350506
1896841262036095
1896841408185119
1896841409413407
1896841419340124
1896841505345565
1896841558655115
1896841609869198
1896841643141697
1896841679440327
1896841714249791
1896841909238533
1896841918179983
1896841923352347
1896841928250229

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NKB102014-05-07
MAX42018-09-27
KWP42010-08-17
ODP22018-07-16
KWQ22018-07-13
HSN22017-11-07
HRS22015-11-25
OVD22014-11-13
JWH22011-03-24
PHX22005-05-27
OUR12016-12-14
OVE12016-09-14
KTT12014-10-10
KWI12014-01-07
MNH12008-07-23
MNI12006-11-16
HWC11994-02-17