FDA.reportPublic FDA data

PARCUS MEDICAL , L.L.C.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30073191073007319107PARCUS MEDICAL , L.L.C.1N2026-01-016423 Parkland Dr Sarasota FL US 34243
30073191073007319107PARCUS MEDICAL , L.L.C.1N2020-04-256423 Parkland Dr Sarasota FL US 34243

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3406541816346930K232513X-Twist Biocomposite Suture AnchorMAI2023-09-18
3406541640959506K221502Parcus Synd-EZ SSMBI2022-07-26
3406541297225332K221135X-Twist PEEK Suture AnchorMBI2022-05-19
3406541190736494K212739ActiFlipMBI2021-10-06
3406541865599663K202662Parcus Titanium Interference ScrewsMBI2021-02-22
3406541347467574K202259Parcus GFS II and GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ Ti, Actiflip Naked, Actiflip Cinch, Actiflip Whip, and GFS Ultimate HipMBI2020-10-28
3406542027646341K201083Parcus V-lox Titanium Suture Anchors, Parcus Miti Suture AnchorsMBI2020-07-23
867811484580773K193295Parcus Knotless PEEK and PEEK CF Push-In Suture AnchorMBI2020-01-23
3406541662434470K193295Parcus Knotless PEEK and PEEK CF Push-In Suture AnchorMBI2020-01-23
3406541007157098K192964Parcus Synd-EZ SSMBI2019-11-22
867811253421021K192964Parcus Synd-EZ SSMBI2019-11-22
3406541340544261K192824Parcus Knotless AP Suture AnchorsMAI2019-11-02
867811634062083K192824Parcus Knotless AP Suture AnchorsMAI2019-11-02
3406541043094227K192750AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate HipMBI2020-01-16
867811813642074K192750AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate HipMBI2020-01-16
3406541387849316K191783Parcus Synd-EZ TiMBI2019-10-09
867811603502758K191783Parcus Synd-EZ TiMBI2019-10-09
867811368459632K190817HS FiberGAT2019-05-01
3406541800891597K190375Parcus ATLASMBI2019-04-24
867811963703246K190375Parcus ATLASMBI2019-04-24
867811329458267K183501Parcus Twist AP Suture AnchorsMAI2019-03-15
3406541751236100K183501Parcus Twist AP Suture AnchorsMAI2019-03-15
867811013195507K183331Parcus GFS BTBMBI2019-02-07
3406541462524220K183331Parcus GFS BTBMBI2019-02-07
3406541296512476K170877Parcus SLiK Fix ScrewMBI2017-06-02
867811939058421K170877Parcus SLiK Fix ScrewMBI2017-06-02
867811811533768K170327Parcus SLiK AnchorsMBI2017-03-30
3406542025712544K170327Parcus SLiK AnchorsMBI2017-03-30
867811205342450K162198GFS UltimateMBI2016-11-18
3406542030691267K162198GFS UltimateMBI2016-11-18
867811027341884K153307HS SutureTapeGAT2016-02-12
3406541211526018K152711Parcus GFS NakedMBI2015-11-20
867811973033586K152711Parcus GFS NakedMBI2015-11-20
3406541349435448K133757GFS II STANDARD, GFS II LARGE, GFS MIMIMBI2014-02-04
867811394992899K133757GFS II STANDARD, GFS II LARGE, GFS MIMIMBI2014-02-04
3406541100847331K122805PARCUS DRAW TIGHT 1.8MM SINGLE-LOADED SUTURE ANCHORMBI2013-02-05
867811589769600K122805PARCUS DRAW TIGHT 1.8MM SINGLE-LOADED SUTURE ANCHORMBI2013-02-05
3406541342065218K120942PARCUS TWIST 4 5MM PEEK SUTURE ANCHOR, PARCUS TWIST 5.5MM PEEK SUTURE ANCHOR & PARCUS TRIPLE TWIST 5.5MM PEEK SUTURE ANCMBI2012-04-20
867811882840116K120942PARCUS TWIST 4 5MM PEEK SUTURE ANCHOR, PARCUS TWIST 5.5MM PEEK SUTURE ANCHOR & PARCUS TRIPLE TWIST 5.5MM PEEK SUTURE ANCMBI2012-04-20
3406541030914880K113730PARCUS 35 KNOTLESS PEEK CF PUSH-IN SUTURE ANCHORS, PARCUS 45 KNOTLESS PEEK CF PUSH-IN SUTURE ANCHORSMBI2012-01-17
867811071756968K113730PARCUS 35 KNOTLESS PEEK CF PUSH-IN SUTURE ANCHORS, PARCUS 45 KNOTLESS PEEK CF PUSH-IN SUTURE ANCHORSMBI2012-01-17
3406541098006069K111000PARCUS 2.0MM / 2.5MM / 3.5MM MITI TITANIUM SUTURE ANCHORHWC2011-07-28
867811942542828K111000PARCUS 2.0MM / 2.5MM / 3.5MM MITI TITANIUM SUTURE ANCHORHWC2011-07-28
3406541200119190K102326PARCUS 3.5MM PEEK CF PUSH-IN SUTURE ANCHORHWC2010-11-15
867811486213312K102326PARCUS 3.5MM PEEK CF PUSH-IN SUTURE ANCHORHWC2010-11-15
3406541951921549K102162PARCUS PEEK CF PUSH-IN SUTURE ANCHORHWC2010-11-10
867812014796771K102162PARCUS PEEK CF PUSH-IN SUTURE ANCHORHWC2010-11-10
867811790096316K100006HS FIBER (POLYBLEND), RIVER BOND, RIVERSILK (SILK), RIVERPRO (POLYPROPYLENE), RIVERLON (NYLON) MODEL VERIES BY SIZE/NEEDGAT2010-05-10
867811181903279K091094PARCUS V-LOX PEEK CF SUTURE ANCHOR, MODELS: 10253, 10254, 10263, 10264MBI2009-09-30
3406541462106134K091094PARCUS V-LOX PEEK CF SUTURE ANCHOR, MODELS: 10253, 10254, 10263, 10264MBI2009-09-30
867811166759566K091093PARCUS PPEK CF INTERFERENCE SCREWHWC2009-09-30
3406541970435508K091093PARCUS PPEK CF INTERFERENCE SCREWHWC2009-09-30
867811247207530K090923PARCUS GRAFT FIXATION SYSTEMMBI2009-06-30
3406541254859702K090923PARCUS GRAFT FIXATION SYSTEMMBI2009-06-30
867811175258908K090075PARCUS V-LOX TITANIUM SUTURE ANCHOR,MODELS: 10251, 10252, 10257, 10258MBI2009-03-06
3406541834941799K090075PARCUS V-LOX TITANIUM SUTURE ANCHOR,MODELS: 10251, 10252, 10257, 10258MBI2009-03-06
3406541430330070K083619PARCUS TINTANIUM INTERFERENCE SCREW, MODELS: 10001-10012, 10014-10016, 10018-10020HWC2009-03-06
867811876989594K083619PARCUS TINTANIUM INTERFERENCE SCREW, MODELS: 10001-10012, 10014-10016, 10018-10020HWC2009-03-06
867811001797295
867811013597371
867811121596406
867811156977497
867811161698725
867811232879961
867811245939052
867811252852904
867811282290207
867811313494044
867811315133925
867811423349656
867811507512052
867811645655889
867811656928893
867811804919314
867811832852781
867811944865586
867811954298206
867812013645349
3406541004270273
3406541069179902
3406541199366863
3406541227040760
3406541275284824
3406541327609893
3406541331751370
3406541347215154
3406541370255350
3406541405632684
3406541881342786
3406541888010624
3406541963569193
3406541964490941

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MBI402022-07-26
HWC102011-07-28
MAI52023-09-18
GAT32019-05-01