FDA.reportPublic FDA data

PARAGON 28

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30086501173008650117PARAGON 281N2026-01-0114445 Grasslands Dr. Englewood CO US 80112

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1199831077493669K981386MANAN BLUNT NEEDLEFPA1998-06-29
1199831952902978K262047Grappler Suture Anchor SystemMBI2026-08-03
1199831530830090K261121Megalodon Dynamic Compression SystemJDR2026-08-06
1199832004370429K253886Grappler Suture Anchor PCFD Tether SystemMBI2026-03-17
1199831483655718K253613Monkey Rings External Ring Fixation SystemKTT2025-12-19
1199831911374121K253591Phantom® Hindfoot TTC/TC Nail SystemHSB2026-03-05
1199831945379636K252106External Fixation Mini Rail SystemKTT2025-09-30
1199831637577992K251862External Fixation Bone DistractorKTT2025-08-11
1199831246847802K251850Phantom® Hindfoot TTC/TC Nail SystemHSB2025-07-14
1199831203920332K250952Baby Gorilla®/Gorilla® Plating SystemHRS2025-07-18
1199831677573124K250641APEX 3D Total Ankle Replacement SystemHSN2025-05-01
1199831267190117K242452Monkey Bars Pin to Bar External Fixation SystemKTT2024-11-01
1199831182844441K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemHRS2024-06-05
1199831817348340K240594Grappler Suture Anchor R3FLEX IOL SystemMBI2024-03-26
1199831076545538K240259APEX 3D Total Ankle Replacement SystemHSN2024-06-24
1199831522940115K234128Phantom Fibula Nail SystemHSB2024-08-22
1199831955472953K232838Monkey RingsTM External Fixation SystemKTT2023-10-12
1199831057399452K231867Grappler Suture Anchor SystemMBI2023-08-21
1199831078558746K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation DevicesHWC2023-10-12
1199831204024276K230550JAWS Nitinol Staple SystemJDR2023-05-11
1199831640640986K223184Phantom Metatarsal Shortening SystemHWC2022-12-16
1199831315503149K223056JAWS Nitinol Staple SystemJDR2023-02-16
1199831166340662K222194Baby Gorilla®/Gorilla® Plating SystemHRS2022-08-19
1199831504467427K222091Grappler Suture Anchor SystemMBI2022-09-14
1199831386342824K221465Baby Gorilla/Gorilla Plating SystemHRS2022-06-17
1199831084737294K212895Paragon 28 External Ring Fixation SystemKTT2021-11-08
1199831302624798K211770R3ACT Stabilization SystemHWC2021-12-25
1199831721438921K211322Paratrooper Plantar Plate Repair SystemMBI2021-08-30
1199831111383830K211112OIC External Fixation SystemKTT2021-05-05
1199832039216340K211076Patient Specific Marking GuidesPBF2022-06-28
1199831582959418K211002Grappler Suture Anchor SystemMBI2021-07-07
1199832038979358K210869Phantom Hindfoot TTC/TC Nail SystemHSB2021-06-28
1199832049780961K210390Apex 3D Total Ankle Replacement SystemHSN2021-03-06
1199831695331858K203511Baby Gorilla/Gorilla Plating SystemHRS2020-12-29
1199831650980121K203385TenoTac Soft Tissue Fixation SystemMBI2021-02-11
1199831971094352K203011Monster Screw SystemHWC2020-11-13
1199831139538852K202019Maven Patient-Specific InstrumentationHSN2021-01-14
1199831240723450K201227Phantom® Hindfoot TTC/TC Nail SystemHSB2020-07-17
1199831865929666K200513DAC Dynamic Active Compression PlateHRS2020-07-22
1199832028019505K200513DAC Dynamic Active Compression PlateHRS2020-07-22
1199831757547833K192994Paragon 28 APEX 3D Total Ankle Replacement SystemHSN2020-07-10
1199831858929712K192674Mixing and Delivery SystemFMF2020-02-18
1199831553372203K192163TTC Phantom® Intramedullary Nail SystemHSB2020-01-31
1199831361265782K191782TTC Phantom Intramedullary Nail SystemHSB2019-09-06
1199831213480138K191227Paratrooper Plantar Plate Repair SystemMBI2020-01-24
1199831970611724K190586Monster® Screw SystemHWC2019-04-03
1199831112536265K190365Baby Gorilla/Gorilla Plating SystemHRS2019-04-12
1199831494124798K183690Tenodesis Screw SystemMBI2019-03-01
1199831665646234K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesHRS2019-01-10
1199831360014085K182898TenoTac Soft Tissue Fixation SystemMBI2019-01-14
1199831763781214K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemHSB2019-01-14
1199831731280891K180239Additive Orthopaedics Patient Specific 3D Printed Bone SegmentsHRS2018-05-16
1199831201980552K171715HammerTube SystemHTY2018-03-05
1199832011015693K170923JAWS(TM) Nitinol Staple SystemJDR2017-07-24
1199832035390843K170693Phantom Small Bone Intramedullary Nail SystemKTW2017-06-19
1199831507889962K170214Additive Orthopaedics Locking Lattice PlateHRS2017-04-13
1199831810425511K163593Additive Orthopaedics Bunion SystemHRS2017-06-20
1199831285114866K162241TITAN 3-D™ Wedge SystemPLF2017-04-03
1199832071510035K160264Additive Orthopaedics Hammertoe Correction SystemHTY2016-06-01
1199831035916106K153378Monster BITE Screw SystemHWC2015-12-21
1199831055872716K153207Additive Orthopaedics Bone Wedge SystemHRS2016-09-07
1199831819319623K151418Monster Screw SystemHWC2015-07-15
1199831280910017K150621OsteoSelect PLUS Demineralized Bone Matrix PuttyMQV2015-08-18
1199832047093613K130498OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTYMBP2013-05-31
1199831799727717K124027MONSTER SCREW SYSTEMHWC2013-04-05
1199831735909246K071004OSTEOCRETE BONE VOID FILLERMQV2009-05-21
1199831214180105H200001
1199831043808264
1199831119118289
1199831132154600
1199831184701861
1199831205361354
1199831213114213
1199831331969513
1199831367004053
1199831426345273
1199831452096078
1199831521584456
1199831602533424
1199831606273101
1199831608559267
1199831619939367
1199831621491641
1199831631867780
1199831632265654
1199831635522294
1199831644427438
1199831726133716
1199831751610554
1199831758672639
1199831759699775
1199831811143975
1199831840741568
1199831851191221
1199831950598882
1199831950634011
1199832015624726
1199832031375721
1199832047911536
1199832051871470

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HRS132025-07-18
MBI122026-08-03
HWC92023-10-12
HSB82026-03-05
KTT72025-12-19
HSN52025-05-01
JDR42026-08-06
HTY22018-03-05
MQV22015-08-18
PBF12022-06-28
FMF12020-02-18
KTW12017-06-19
PLF12017-04-03
MBP12013-05-31
FPA11998-06-29

PMN#