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
00889795097972Phantom Hindfoot TTC/TC Nail SystemP31-955-1550P31-955-15502020-12-15
00889795154668Primal OCDP69-900-0004-SKP69-900-0004-SK2026-07-14
00889795154675Primal OCDP69-900-0006-SKP69-900-0006-SK2026-07-14
00889795154682Primal OCDP69-900-0008-SKP69-900-0008-SK2026-07-14
00889795154507Spider Monkey Bone Transport SystemP38-300-2810P38-300-28102026-06-10
00889795154514Spider Monkey Bone Transport SystemP38-300-2410P38-300-24102026-06-10
00889795154521Spider Monkey Bone Transport SystemP38-300-3210P38-300-32102026-06-10
00889795154538Spider Monkey Bone Transport SystemP38-900-0001P38-900-00012026-06-10
00889795154545Spider Monkey Bone Transport SystemP38-900-0002P38-900-00022026-06-10
00889795154552Spider Monkey Bone Transport SystemP38-910-0001P38-910-00012026-06-10
00889795154569Spider Monkey Bone Transport SystemP38-910-0002P38-910-00022026-06-10
00889795154576Spider Monkey Bone Transport SystemP38-910-0003P38-910-00032026-06-10
00889795154583Spider Monkey Bone Transport SystemP38-900-BONBP38-900-BONB2026-06-10
00889795154590Spider Monkey Bone Transport SystemP38-900-BONLP38-900-BONL2026-06-10
00889795154606Spider Monkey Bone Transport SystemP38-300-4016P38-300-40162026-06-10
00889795154613Spider Monkey Bone Transport SystemP38-900-0003P38-900-00032026-06-10
00889795154620Spider Monkey Bone Transport SystemP38-210-320BP38-210-320B2026-06-10
00889795154637Spider Monkey Bone Transport SystemP38-210-420BP38-210-420B2026-06-10
00889795154644Spider Monkey Bone Transport SystemP38-211-320BP38-211-320B2026-06-10
00889795154651Spider Monkey Bone Transport SystemP38-211-420BP38-211-420B2026-06-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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18059015376869Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015376876Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
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18059015376890Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015376906Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015376913Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015376920Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015376937Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015376944Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
18059015376951Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
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18059015376982Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
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18059015377019Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
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18059015377033Fitbone Transport and Lengthening SystemORTHOFIX SRLHSB2026-07-23
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