X-Twist Biocomposite Suture Anchor
Parcus Medical
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3007319107 | 3007319107 | PARCUS MEDICAL , L.L.C. | 1 | N | 2026-01-01 | 6423 Parkland Dr Sarasota FL US 34243 |
| 3007319107 | 3007319107 | PARCUS MEDICAL , L.L.C. | 1 | N | 2020-04-25 | 6423 Parkland Dr Sarasota FL US 34243 |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 340654 | 1816346930 | K232513 | X-Twist Biocomposite Suture Anchor | MAI | 2023-09-18 |
| 340654 | 1640959506 | K221502 | Parcus Synd-EZ SS | MBI | 2022-07-26 |
| 340654 | 1297225332 | K221135 | X-Twist PEEK Suture Anchor | MBI | 2022-05-19 |
| 340654 | 1190736494 | K212739 | ActiFlip | MBI | 2021-10-06 |
| 340654 | 1865599663 | K202662 | Parcus Titanium Interference Screws | MBI | 2021-02-22 |
| 340654 | 1347467574 | K202259 | Parcus GFS II and GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ Ti, Actiflip Naked, Actiflip Cinch, Actiflip Whip, and GFS Ultimate Hip | MBI | 2020-10-28 |
| 340654 | 2027646341 | K201083 | Parcus V-lox Titanium Suture Anchors, Parcus Miti Suture Anchors | MBI | 2020-07-23 |
| 86781 | 1484580773 | K193295 | Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor | MBI | 2020-01-23 |
| 340654 | 1662434470 | K193295 | Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor | MBI | 2020-01-23 |
| 340654 | 1007157098 | K192964 | Parcus Synd-EZ SS | MBI | 2019-11-22 |
| 86781 | 1253421021 | K192964 | Parcus Synd-EZ SS | MBI | 2019-11-22 |
| 340654 | 1340544261 | K192824 | Parcus Knotless AP Suture Anchors | MAI | 2019-11-02 |
| 86781 | 1634062083 | K192824 | Parcus Knotless AP Suture Anchors | MAI | 2019-11-02 |
| 340654 | 1043094227 | K192750 | AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate Hip | MBI | 2020-01-16 |
| 86781 | 1813642074 | K192750 | AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate Hip | MBI | 2020-01-16 |
| 340654 | 1387849316 | K191783 | Parcus Synd-EZ Ti | MBI | 2019-10-09 |
| 86781 | 1603502758 | K191783 | Parcus Synd-EZ Ti | MBI | 2019-10-09 |
| 86781 | 1368459632 | K190817 | HS Fiber | GAT | 2019-05-01 |
| 340654 | 1800891597 | K190375 | Parcus ATLAS | MBI | 2019-04-24 |
| 86781 | 1963703246 | K190375 | Parcus ATLAS | MBI | 2019-04-24 |
| 86781 | 1329458267 | K183501 | Parcus Twist AP Suture Anchors | MAI | 2019-03-15 |
| 340654 | 1751236100 | K183501 | Parcus Twist AP Suture Anchors | MAI | 2019-03-15 |
| 86781 | 1013195507 | K183331 | Parcus GFS BTB | MBI | 2019-02-07 |
| 340654 | 1462524220 | K183331 | Parcus GFS BTB | MBI | 2019-02-07 |
| 340654 | 1296512476 | K170877 | Parcus SLiK Fix Screw | MBI | 2017-06-02 |
| 86781 | 1939058421 | K170877 | Parcus SLiK Fix Screw | MBI | 2017-06-02 |
| 86781 | 1811533768 | K170327 | Parcus SLiK Anchors | MBI | 2017-03-30 |
| 340654 | 2025712544 | K170327 | Parcus SLiK Anchors | MBI | 2017-03-30 |
| 86781 | 1205342450 | K162198 | GFS Ultimate | MBI | 2016-11-18 |
| 340654 | 2030691267 | K162198 | GFS Ultimate | MBI | 2016-11-18 |
| 86781 | 1027341884 | K153307 | HS SutureTape | GAT | 2016-02-12 |
| 340654 | 1211526018 | K152711 | Parcus GFS Naked | MBI | 2015-11-20 |
| 86781 | 1973033586 | K152711 | Parcus GFS Naked | MBI | 2015-11-20 |
| 340654 | 1349435448 | K133757 | GFS II STANDARD, GFS II LARGE, GFS MIMI | MBI | 2014-02-04 |
| 86781 | 1394992899 | K133757 | GFS II STANDARD, GFS II LARGE, GFS MIMI | MBI | 2014-02-04 |
| 340654 | 1100847331 | K122805 | PARCUS DRAW TIGHT 1.8MM SINGLE-LOADED SUTURE ANCHOR | MBI | 2013-02-05 |
| 86781 | 1589769600 | K122805 | PARCUS DRAW TIGHT 1.8MM SINGLE-LOADED SUTURE ANCHOR | MBI | 2013-02-05 |
| 340654 | 1342065218 | K120942 | PARCUS TWIST 4 5MM PEEK SUTURE ANCHOR, PARCUS TWIST 5.5MM PEEK SUTURE ANCHOR & PARCUS TRIPLE TWIST 5.5MM PEEK SUTURE ANC | MBI | 2012-04-20 |
| 86781 | 1882840116 | K120942 | PARCUS TWIST 4 5MM PEEK SUTURE ANCHOR, PARCUS TWIST 5.5MM PEEK SUTURE ANCHOR & PARCUS TRIPLE TWIST 5.5MM PEEK SUTURE ANC | MBI | 2012-04-20 |
| 340654 | 1030914880 | K113730 | PARCUS 35 KNOTLESS PEEK CF PUSH-IN SUTURE ANCHORS, PARCUS 45 KNOTLESS PEEK CF PUSH-IN SUTURE ANCHORS | MBI | 2012-01-17 |
| 86781 | 1071756968 | K113730 | PARCUS 35 KNOTLESS PEEK CF PUSH-IN SUTURE ANCHORS, PARCUS 45 KNOTLESS PEEK CF PUSH-IN SUTURE ANCHORS | MBI | 2012-01-17 |
| 340654 | 1098006069 | K111000 | PARCUS 2.0MM / 2.5MM / 3.5MM MITI TITANIUM SUTURE ANCHOR | HWC | 2011-07-28 |
| 86781 | 1942542828 | K111000 | PARCUS 2.0MM / 2.5MM / 3.5MM MITI TITANIUM SUTURE ANCHOR | HWC | 2011-07-28 |
| 340654 | 1200119190 | K102326 | PARCUS 3.5MM PEEK CF PUSH-IN SUTURE ANCHOR | HWC | 2010-11-15 |
| 86781 | 1486213312 | K102326 | PARCUS 3.5MM PEEK CF PUSH-IN SUTURE ANCHOR | HWC | 2010-11-15 |
| 340654 | 1951921549 | K102162 | PARCUS PEEK CF PUSH-IN SUTURE ANCHOR | HWC | 2010-11-10 |
| 86781 | 2014796771 | K102162 | PARCUS PEEK CF PUSH-IN SUTURE ANCHOR | HWC | 2010-11-10 |
| 86781 | 1790096316 | K100006 | HS FIBER (POLYBLEND), RIVER BOND, RIVERSILK (SILK), RIVERPRO (POLYPROPYLENE), RIVERLON (NYLON) MODEL VERIES BY SIZE/NEED | GAT | 2010-05-10 |
| 86781 | 1181903279 | K091094 | PARCUS V-LOX PEEK CF SUTURE ANCHOR, MODELS: 10253, 10254, 10263, 10264 | MBI | 2009-09-30 |
| 340654 | 1462106134 | K091094 | PARCUS V-LOX PEEK CF SUTURE ANCHOR, MODELS: 10253, 10254, 10263, 10264 | MBI | 2009-09-30 |
| 86781 | 1166759566 | K091093 | PARCUS PPEK CF INTERFERENCE SCREW | HWC | 2009-09-30 |
| 340654 | 1970435508 | K091093 | PARCUS PPEK CF INTERFERENCE SCREW | HWC | 2009-09-30 |
| 86781 | 1247207530 | K090923 | PARCUS GRAFT FIXATION SYSTEM | MBI | 2009-06-30 |
| 340654 | 1254859702 | K090923 | PARCUS GRAFT FIXATION SYSTEM | MBI | 2009-06-30 |
| 86781 | 1175258908 | K090075 | PARCUS V-LOX TITANIUM SUTURE ANCHOR,MODELS: 10251, 10252, 10257, 10258 | MBI | 2009-03-06 |
| 340654 | 1834941799 | K090075 | PARCUS V-LOX TITANIUM SUTURE ANCHOR,MODELS: 10251, 10252, 10257, 10258 | MBI | 2009-03-06 |
| 340654 | 1430330070 | K083619 | PARCUS TINTANIUM INTERFERENCE SCREW, MODELS: 10001-10012, 10014-10016, 10018-10020 | HWC | 2009-03-06 |
| 86781 | 1876989594 | K083619 | PARCUS TINTANIUM INTERFERENCE SCREW, MODELS: 10001-10012, 10014-10016, 10018-10020 | HWC | 2009-03-06 |
| 86781 | 1001797295 | ||||
| 86781 | 1013597371 | ||||
| 86781 | 1121596406 | ||||
| 86781 | 1156977497 | ||||
| 86781 | 1161698725 | ||||
| 86781 | 1232879961 | ||||
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| 86781 | 1252852904 | ||||
| 86781 | 1282290207 | ||||
| 86781 | 1313494044 | ||||
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| 86781 | 1423349656 | ||||
| 86781 | 1507512052 | ||||
| 86781 | 1645655889 | ||||
| 86781 | 1656928893 | ||||
| 86781 | 1804919314 | ||||
| 86781 | 1832852781 | ||||
| 86781 | 1944865586 | ||||
| 86781 | 1954298206 | ||||
| 86781 | 2013645349 | ||||
| 340654 | 1004270273 | ||||
| 340654 | 1069179902 | ||||
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| 340654 | 1881342786 | ||||
| 340654 | 1888010624 | ||||
| 340654 | 1963569193 | ||||
| 340654 | 1964490941 |
Parcus Medical
Parcus Medical, LLC
Parcus Medical LLC
Parcus Medical LLC.
Parcus Medical, LLC
Parcus Medical, LLC
Parcus Medical, LLC
Parcus Medical, LLC
Parcus Medical, LLC
Parcus Medical, LLC
Parcus Medical, LLC
Parcus Medical, LLC
Parcus Medical, LLC
Parcus Medical, LLC
Parcus Medical, LLC
Parcus Medical
Parcus Medical
PARCUS MEDICAL, LLC
PARCUS MEDICAL, LLC
PARCUS MEDICAL, LLC
PARCUS MEDICAL, LLC
PARCUS MEDICAL, LLC
PARCUS MEDICAL, LLC
PARCUS MEDICAL, LLC
PARCUS MEDICAL, LLC
PARCUS MEDICAL, LLC
PARCUS MEDICAL, LLC
PARCUS MEDICAL, LLC
PARCUS MEDICAL, LLC
PARCUS MEDICAL, LLC
PARCUS MEDICAL, LLC
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