FDA.reportPublic FDA data

Phantom Hindfoot TTC/TC Nail System

Primary DI
00889795146311
Brand
Phantom Hindfoot TTC/TC Nail System
Company
Paragon 28, Inc.
Model
P32-959-0160
Catalog number
P32-959-0160
Device description
Phantom Curved Nail, 14.0mm Nail Reamer
Published
2025-11-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K210869000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210869000Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.2021-06-28HSB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889795146311PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889795146311008897951463118897951463110889795146311

GMDN Terms#

Term, Definition table
TermDefinition
Bone-resection orthopaedic reamer, single-useAn orthopaedic surgical instrument intended to resect bone (cut out part of the bone), and in some cases hypertrophic tissue [e.g., ligamentum flavum], to: 1) accept a prosthetic implant, typically at or within a joint (e.g., condyle of knee, neck of humerus, olecranon of ulna); and/or 2) relieve pressure at or facilitate access to a joint. Commonly called a mill or a reamer, it is typically designed as a stainless steel cylindrical body with an end/circumferential cutting edge and is attached to a shaft for manual or powered rotation. This is a single-use device.

Regulatory Flags#

DUNS number
042961576
Device count
1
Kit
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