Singapore HSA registration DE0507281

Paragon28 Phantom™ Hindfoot TTC Nail System

Singapore·CLASS C·Paragon 28, Inc·Registered September 20, 2022

Device classification

Device Class: CLASS C
Medical Speciality Area: Orthopaedics

Registration information

Registration Number: DE0507281
Registration Date: September 20, 2022
Retention Due Date: September 19, 2025

Product description

The Paragon28 Phantom Hindfoot TTC Nail System is indicated for use in stabilization and fixation of the small bones of the feet and ankle for the treatment of fractures, osteotomies, nonunions, pseudoarthroses and malunions caused by revision, joint fusion or reconstruction procedures.

Product Owner

Name: Paragon 28, Inc
Short Name: Paragon 28, Inc
Address: 14445 Grasslands Drive, Englewood, Colorado, 80112, UNITED STATES

Registrant

Name: GEN-Y (S) PTE. LTD.
Address: 8 JALAN KILANG TIMOR, KEWALRAM HOUSE, #03-04A, SINGAPORE 159305

Importer

Name: GEN-Y (S) PTE. LTD.
Address: 8 JALAN KILANG TIMOR, KEWALRAM HOUSE, #03-04A, SINGAPORE 159305

Model information

Model Name(s): Phantom Nail, Internal Compression Screw Phantom Nail, Shouldered End Cap, Short Phantom Nail, Shouldered End Cap, Long Phantom Nail, Compression End Cap, Short Phantom Nail, Compression End Cap, Long Phantom TTC Nail, 10.0 X 150mm, LEFT STERILE Phantom TTC Nail, 10.0 X 150mm, RIGHT STERILE Phantom TTC Nail, 10.0 X 200mm, LEFT STERILE Phantom TTC Nail, 10.0 X 200mm, RIGHT STERILE Phantom TTC Nail, 10.0 X 250mm, LEFT STERILE Phantom TTC Nail, 10.0 X 250mm, RIGHT STERILE Phantom TTC Nail, 10.0 X 300mm, LEFT STERILE Phantom TTC Nail, 10.0 X 300mm, RIGHT STERILE Phantom TTC Nail, 11.5 X 150mm, LEFT STERILE Phantom TTC Nail, 11.5 X 150mm, RIGHT STERILE Phantom TTC Nail, 11.5 X 200mm, LEFT STERILE Phantom TTC Nail, 11.5 X 200mm, RIGHT STERILE Phantom TTC Nail, 11.5 X 250mm, LEFT STERILE Phantom TTC Nail, 11.5 X 250mm, RIGHT STERILE Phantom TTC Nail, 11.5 X 300mm, LEFT STERILE Phantom TTC Nail, 11.5 X 300mm, RIGHT STERILE Phantom TTC Nail, 13.0 X 150mm, LEFT STERILE Phantom TTC Nail, 13.0 X 150mm, RIGHT STERILE Phantom TTC Nail, 13.0 X 175mm, LEFT STERILE Phantom TTC Nail, 13.0 X 175mm, RIGHT STERILE Phantom TTC Nail, 13.0 X 200mm, LEFT STERILE Phantom TTC Nail, 13.0 X 200mm, RIGHT STERILE Phantom TTC Nail, 13.0 X 250mm, LEFT STERILE Phantom TTC Nail, 13.0 X 250mm, RIGHT STERILE Phantom Nail, Full Thread, 7.2mm x 45mm, Headless Phantom Nail, Full Thread, 7.2mm x 50mm, Headless Phantom Nail, Full Thread, 7.2mm x 55mm, Headless Phantom Nail, Calcaneus Screw, 7.2mm x 60mm, Headless Phantom Nail, Calcaneus Screw, 7.2mm x 65mm, Headless Phantom Nail, Calcaneus Screw, 7.2mm x 70mm, Headless Phantom Nail, Calcaneus Screw, 7.2mm x 75mm, Headless Phantom Nail, Calcaneus Screw, 7.2mm x 80mm, Headless Phantom Nail, Calcaneus Screw, 7.2mm x 85mm, Headless Phantom Nail, Calcaneus Screw, 7.2mm x 90mm, Headless Phantom Nail, Calcaneus Screw, 7.2mm x 95mm, Headless Phantom Nail, Calcaneus Screw, 7.2mm x 100mm, Headless Phantom Nail, Calcaneus Screw, 7.2mm x 105mm, Headless Phantom Nail, Calcaneus Screw, 7.2mm x 110mm, Headless Phantom Nail, Calcaneus Screw, 7.2mm x 115mm, Headless Phantom Nail, Calcaneus Screw, 7.2mm x 120mm, Headless Reamer, Flexible Shaft, 345mm Reamer, Flexible Shaft, 417mm Reamer Cutting Head, 8.0mm Reamer Cutting Head, 8.5mm Reamer Cutting Head, 9.0mm Reamer Cutting Head, 9.5mm Reamer Cutting Head, 10.0mm Reamer Cutting Head, 10.5mm Reamer Cutting Head, 11.0mm Reamer Cutting Head, 11.5mm Reamer Cutting Head, 12.0mm Reamer Cutting Head, 12.5mm Reamer Cutting Head, 13.0mm Reamer Cutting Head, 13.5mm Reamer Cutting Head, 14.0mm Phantom Nail, Crossing Screw, Headed �5.0mm x 20mm Phantom Nail, Crossing Screw, �5.0mm x 22mm length, Headed Phantom Nail, Crossing Screw, �5.0mm x 24mm length, Headed Phantom Nail, Crossing Screw, �5.0mm x 26mm length, Headed Phantom Nail, Crossing Screw, �5.0mm x 28mm length, Headed Phantom Nail, Crossing Screw, �5.0mm x 30mm length, Headed Phantom Nail, Crossing Screw, �5.0mm x 32mm length, Headed Phantom Nail, Crossing Screw, �5.0mm x 34mm length, Headed Phantom Nail, Crossing Screw, �5.0mm x 36mm length, Headed Phantom Nail, Crossing Screw, �5.0mm x 38mm length, Headed Phantom Nail, Crossing Screw, �5.0mm x 40mm length, Headed Phantom Nail, Crossing Screw, �5.0mm x 42mm length, Headed Phantom Nail, Crossing Screw, �5.0mm x 44mm length, Headed Phantom Nail, Crossing Screw, �5.0mm x 46mm length, Headed Phantom Nail, Crossing Screw, �5.0mm x 48mm length, Headed Phantom Nail, Crossing Screw, �5.0mm x 50mm length, Headed Phantom Nail, Crossing Screw, �5.0mm x 52mm length, Headed Phantom Nail, Crossing Screw, �5.0mm x 54mm length, Headed Phantom Nail, Crossing Screw, �5.0mm x 56mm length, Headed Phantom Nail, Crossing Screw, �5.0mm x 58mm length, Headed Phantom Nail, Crossing Screw, �5.0mm x 60mm length, Headed Phantom Nail, Full Thread, 5.0mm x 62mm, Headed Phantom Nail, Full Thread, 5.0mm x 64mm, Headed Phantom Nail, Full Thread, 5.0mm x 66mm, Headed Phantom Nail, Full Thread, 5.0mm x 68mm, Headed Phantom Nail, Full Thread, 5.0mm x 70mm, Headed Drill, 3.8 X 250mm Drill, Solid, Trocar Tip, 3/16" Sq. Connection �4.6 X 300mm Drill, Solid, Trocar Tip Barrel Burr, 6.0, 55mm OAL, J-Notch STERILE Oval Burr, 6.0, 55mm OAL, J-Notch STERILE Step Drill Drill, 4.6 x 300mm, Cannulated, 3/16" Sq. Connection Drill, 7.0 x 200mm
Model Identifier(s): P31-101-0000-03 P31-102-0001 P31-102-0005 P31-111-0000-03 P31-111-0000-07 P31-300-150L-S P31-300-150R-S P31-300-200L-S P31-300-200R-S P31-300-250L-S P31-300-250R-S P31-300-300L-S P31-300-300R-S P31-315-150L-S P31-315-150R-S P31-315-200L-S P31-315-200R-S P31-315-250L-S P31-315-250R-S P31-315-300L-S P31-315-300R-S P31-330-150L-S P31-330-150R-S P31-330-175L-S P31-330-175R-S P31-330-200L-S P31-330-200R-S P31-330-250L-S P31-330-250R-S P31-772-045F P31-772-050F P31-772-055F P31-772-060F P31-772-065F P31-772-070F P31-772-075F P31-772-080F P31-772-085F P31-772-090F P31-772-095F P31-772-100F P31-772-105F P31-772-110F P31-772-115F P31-772-120F P31-954-0345 P31-954-0417 P31-955-0080 P31-955-0085 P31-955-0090 P31-955-0095 P31-955-0100 P31-955-0105 P31-955-0110 P31-955-0115 P31-955-0120 P31-955-0125 P31-955-0130 P31-955-0135 P31-955-0140 P32-450-020F P32-450-022F P32-450-024F P32-450-026F P32-450-028F P32-450-030F P32-450-032F P32-450-034F P32-450-036F P32-450-038F P32-450-040F P32-450-042F P32-450-044F P32-450-046F P32-450-048F P32-450-050F P32-450-052F P32-450-054F P32-450-056F P32-450-058F P32-450-060F P32-450-062F P32-450-064F P32-450-066F P32-450-068F P32-450-070F P99-100-3825 P99-100-4630 P99-106-6005-S P99-107-6005-S P99-110-0813 P99-110-4630 P99-110-7019

About this record

Access comprehensive regulatory information for Paragon28 Phantom™ Hindfoot TTC Nail System in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0507281 and owned by Paragon 28, Inc. The device was registered on September 20, 2022.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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