FDA.reportPublic FDA data

Small Bone Phantom Intramedullary Nail System

Primary DI
00889795038647
Brand
Small Bone Phantom Intramedullary Nail System
Company
Paragon 28, Inc.
Model
P30-900-040L
Catalog number
P30-900-040L
Device description
Lapidus Nail, Outrigger Slider, 50mm/52mm, Left
Published
2019-10-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
KTWAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, SINGLE COMPONENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KTWAppliance, Fixation, Nail/Blade/Plate Combination, Single ComponentOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182307000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182307000Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.2019-01-14HSB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889795038647PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889795038647008897950386478897950386470889795038647

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant aiming/guiding block, reusableA surgical, jig-like device designed as a preshaped block with a defined pattern of prefabricated holes used to guide other instruments [e.g., drill sleeves and guide wires (Kirschner wires)] and/or to align a corresponding implant (e.g., a fixation plate) during an orthopaedic procedure. It is typically made of metallic or synthetic materials and may have an attachment point for an implant. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
042961576
Device count
1
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10886982218735NASYNTHES (U.S.A.) LPKTW2018-07-18
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