Paragon 28

FDA Filings

This page includes the latest FDA filings for Paragon 28. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3008650117
FEI Number3008650117
NamePARAGON 28
Owner & OperatorParagon 28
Contact Address14445 Grasslands Dr.
Englewood CO 80112 US
Official Correspondent
  • Eric Lintula
  • 1-855-7862828-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address14445 Grasslands Dr.
Englewood, CO 80112 US
Establishment TypeComplaint File Establishment per 21 CFR 820.198



FDA Filings

Device
Company
DeviceDate
PARAGON 28
Paratrooper Plantar Plate Repair System2020-04-09
PARAGON 28
Paratrooper Plantar Plate Repair System2020-04-09
PARAGON 28
Phantom Hindfoot TTC/TC Nail System2020-02-07
PARAGON 28
Phantom ActivCore Nail2020-02-07
PARAGON 28
Phantom Hindfoot TTC/TC Nail System2020-02-07
PARAGON 28
Phantom ActivCore Nail2020-02-07
PARAGON 28
Phantom TTC Nail2020-01-21
PARAGON 28
Phantom TC Nail2020-01-21
PARAGON 28
Phantom Hindfoot System2020-01-21
PARAGON 28
Phantom TTC Nail2020-01-21
PARAGON 28
Phantom TC Nail2020-01-21
PARAGON 28
Phantom Hindfoot System2020-01-21
PARAGON 28
Driver2019-08-21
PARAGON 28
Template2019-08-21
PARAGON 28
Extractor2019-08-21
PARAGON 28
Bone Planer2019-08-21
PARAGON 28
Rongeur2019-08-21
PARAGON 28
Depth Gauge2019-08-21
PARAGON 28
Surgical Instrument motos and accessories/attachments2019-08-21
PARAGON 28
Surgical instrument cleaning brush/tool2019-08-21
PARAGON 28
San Gio? Baby Bennetts2019-08-21
PARAGON 28
Bone Marrow Harvest Needle2019-08-21
PARAGON 28
Grappler Interference Screw System2019-08-15
PARAGON 28
Monster Screw System2019-06-13
PARAGON 28
PRECISION Jones Fracture System2019-06-03
PARAGON 28
Monster Screw System2019-06-03
PARAGON 28
Monster BITE Screw System2019-06-03
PARAGON 28
Joust Beaming Screw System2019-06-03
PARAGON 28
Silverback Ankle Fusion Plating System2019-06-03
PARAGON 28
R3LEASE Stabilization System2019-06-03
PARAGON 28
PROMO Correction System2019-06-03
PARAGON 28
Gorilla Plating System2019-06-03
PARAGON 28
Baby Gorilla Plating System2019-06-03
PARAGON 28
BOW & ARROW Plates2019-06-03
PARAGON 28
Silverback Ankle Fusion Plating System2019-06-03
PARAGON 28
R3LEASE Stabilization System2019-06-03
PARAGON 28
PROMO Correction System2019-06-03
PARAGON 28
Gorilla Plating System2019-06-03
PARAGON 28
Baby Gorilla Plating System2019-06-03
PARAGON 28
BOW & ARROW Plates2019-06-03
PARAGON 28
Silverback Ankle Fusion Plating System2019-06-03
PARAGON 28
R3LEASE Stabilization System2019-06-03
PARAGON 28
PROMO Correction System2019-06-03
PARAGON 28
Gorilla Plating System2019-06-03
PARAGON 28
Baby Gorilla Plating System2019-06-03
PARAGON 28
BOW & ARROW Plates2019-06-03
PARAGON 28
Small Bone Phantom Intramedullary Nail System2019-06-03
PARAGON 28
Small Bone Phantom Intramedullary Nail System2019-06-03
PARAGON 28
Small Bone Phantom Intramedullary Nail System2019-06-03
PARAGON 28
HammerTube System2019-06-03
PARAGON 28
TenoTac Soft Tissue Fixation System2019-02-21
PARAGON 28
Forceps2019-02-21
PARAGON 28
Passer2019-01-18
PARAGON 28
Bone Hook2018-12-13
PARAGON 28
Plate Bender2018-12-13
PARAGON 28
Osteotome2018-12-13
PARAGON 28
Trephine2018-12-13
PARAGON 28
Rasp2018-12-13
PARAGON 28
Curette2018-12-13
PARAGON 28
Tissue Protector2018-12-13
PARAGON 28
Drill Guide2018-12-13
Paragon 28
HammerTube System2018-03-05
PARAGON 28
Monster Screw System2018-01-29
PARAGON 28
Monster Screw System2018-01-29
Paragon 28
Breakaway Screw System2017-12-20
PARAGON 28
JAWS Nitinol Staple System2017-07-26
PARAGON 28
Small Bone Phantom? Intramedullary Nail System2017-07-26
PARAGON 28
Small Bone Phantom? Intramedullary Nail System2017-07-26
PARAGON 28
Titan 3-D Wedge System2017-07-26
PARAGON 28
Titan 3-D Wedge System2017-07-26
Paragon 28
JAWS(TM) Nitinol Staple System2017-07-24
PARAGON 28
TITAN 3-D™ Wedge System2017-04-03
PARAGON 28
Tray2016-09-13
PARAGON 28
Case2016-09-13
PARAGON 28
Caddy2016-09-13
PARAGON 28
Tap2016-09-09
PARAGON 28
Monster BITE Screw System2015-12-21
PARAGON 28
Monster Screw System2015-07-15
PARAGON 28
PARALOCK PLATING SYSTEM / TUFFNEK SCREW2014-04-17
PARAGON 28
Monster Screw System2013-12-16
PARAGON 28
Monster Screw System2013-12-16
PARAGON 28
Distractor2013-05-01
PARAGON 28
Compressor2013-05-01
PARAGON 28
Trial2013-04-28
PARAGON 28
Tamp2013-04-28
PARAGON 28
Drill bit2013-04-28
PARAGON 28
Reamer2013-04-28

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