FDA.reportPublic FDA data

Phantom Hindfoot TTC/TC Nail System

Primary DI
00889795149879
Brand
Phantom Hindfoot TTC/TC Nail System
Company
Paragon 28, Inc.
Model
P31-830-300L-S
Catalog number
P31-830-300L-S
Device description
Phantom Nail, Static Straight, TTC, 13mm X 300mm, LEFT
Published
2025-08-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HSBROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSBRod, Fixation, Intramedullary And AccessoriesOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K251850000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251850000Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.2025-07-14HSB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889795149879PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889795149879008897951498798897951498790889795149879

GMDN Terms#

Term, Definition table
TermDefinition
Arthrodesis intramedullary nail, non-distractingA rigid rod, not intended for bone distraction, dedicated to arthrodesis/joint fusion through implantation into the intramedullary canal of a long bone [e.g., femur, tibia, humerus (including fixation of the glenoid), fibula, radius, ulna] which extends beyond the joint to an adjacent bone(s), as part of traumatic repair or reconstructive procedures. It may be of fixed or variable length to allow compression (dynamic). It is intended to be fixed to the bone with screws which may be included with the nail. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
042961576
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889795150073APEX 3D Total Ankle Replacement SystemP11-700-TEMPP11-700-TEMP2026-10-12
00889795150080APEX 3D Total Ankle Replacement SystemP11-710-TUF1P11-710-TUF12026-10-12
00889795150097APEX 3D Total Ankle Replacement SystemP11-710-TUF2P11-710-TUF22026-10-12
00889795150103APEX 3D Total Ankle Replacement SystemP11-710-TUF3P11-710-TUF32026-10-12
00889795150110APEX 3D Total Ankle Replacement SystemP11-710-TUF4P11-710-TUF42026-10-12
00889795150127APEX 3D Total Ankle Replacement SystemP11-710-TUF5P11-710-TUF52026-10-12
00889795150134APEX 3D Total Ankle Replacement SystemP11-710-TUF6P11-710-TUF62026-10-12
00889795150141APEX 3D Total Ankle Replacement SystemP11-754-CS12P11-754-CS122026-10-12
00889795150158APEX 3D Total Ankle Replacement SystemP11-754-CT12P11-754-CT122026-10-12
00889795150165APEX 3D Total Ankle Replacement SystemP11-754-CS14P11-754-CS142026-10-12
00889795150172APEX 3D Total Ankle Replacement SystemP11-754-CT14P11-754-CT142026-10-12
00889795150189APEX 3D Total Ankle Replacement SystemP11-754-CS16P11-754-CS162026-10-12
00889795150196APEX 3D Total Ankle Replacement SystemP11-754-CT16P11-754-CT162026-10-12
00889795150202APEX 3D Total Ankle Replacement SystemP11-754-DS12P11-754-DS122026-10-12
00889795150219APEX 3D Total Ankle Replacement SystemP11-754-DT12P11-754-DT122026-10-12
00889795150226APEX 3D Total Ankle Replacement SystemP11-754-DS14P11-754-DS142026-10-12
00889795150233APEX 3D Total Ankle Replacement SystemP11-754-DT14P11-754-DT142026-10-12
00889795150240APEX 3D Total Ankle Replacement SystemP11-754-DS16P11-754-DS162026-10-12
00889795150257APEX 3D Total Ankle Replacement SystemP11-754-DT16P11-754-DT162026-10-12
00889795150264APEX 3D Total Ankle Replacement SystemP11-754-WR01P11-754-WR012026-10-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M97012000112300DynaNailMedshape, Inc.HSB2026-10-16
08056693086397ELOS INSTRUMENTSINTRAUMA SPAHSB2026-10-13
08056693086403ELOS INSTRUMENTSINTRAUMA SPAHSB2026-10-13
08056693086410ELOS INSTRUMENTSINTRAUMA SPAHSB2026-10-13
00817867021044PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021051PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021068PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021075PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021082PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021099PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021105PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021112PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021129PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021136PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021143PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021150PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021167PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021174PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021181PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021198PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021204PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021211PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021228PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021235PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021242PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021259PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021266PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021273PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021280PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021297PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01