FDA.reportPublic FDA data

AMDT Mini-Rail

Primary DI
00850030203786
Brand
AMDT Mini-Rail
Company
Amdt Holdings, Inc.
Model
1
Catalog number
M732
Device description
Bone Screw ø3.0 mm X 60mm long, 20mm thread
Published
2021-04-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162032000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162032000Arrowhead Mini-Rail FixatorArrowhead De, LLC2017-02-21KTT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850030203786PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850030203786008500302037868500302037860850030203786

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone pin, non-bioabsorbableA small diameter rod typically used for the fixation of a bone fracture or bone grafts, or for an osteotomy or arthrodesis. The rod may be smooth, wholly- or partially-threaded, solid or cannulated, and some designs may be tapered; it is not specific to the clavicle bone. The device is made of a material that is not chemically degraded or absorbed by natural body processes (e.g., implant grade metal, surgical steel, titanium alloy, or carbon fibre). Some designs may have a break-off shank and/or may be coated [e.g., with hydroxyapatite, also known as hydroxylapatite (HA)] to improve purchase in osteoporotic bone and for long-term fixation. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
901-853-4366INFO@AMDTHoldings.com

Regulatory Flags#

DUNS number
117990191
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850030203793AMDT Mini-Rail1M7342021-04-12
00850030203809AMDT Mini-Rail1M7382021-04-12
00850030203816AMDT Mini-Rail1M7392021-04-12
00850030203823AMDT Mini-Rail1M7452021-04-12
00850030203830AMDT Mini-Rail1M7462021-04-12
00850030203847AMDT Mini-Rail1M7472021-04-12
00850030203878AMDT Mini-Rail1M7432021-04-12
00850030203885AMDT Mini-Rail1M7442021-04-12
00850030203939Six Fix Circular Fixation System16410184002023-08-04
00850030203946Six Fix Circular Fixation System16414204502023-08-04
00850030203953Six Fix Circular Fixation System16430204002023-08-04
00850030203960Six Fix Circular Fixation System16435184002023-08-04
00850030203106SixFix Circular Fixation System176-114502021-04-13
00850030203113SixFix Circular Fixation System176-101122021-04-13
00850030203205SixFix Circular Fixation System176-102092021-04-15
00850030203212SixFix Circular Fixation System176-102102021-04-15
00850030203229SixFix Circular Fixation System176-110852021-04-15
00850030203236SixFix Circular Fixation System176-111152021-04-15
00850030203243SixFix Circular Fixation System176-112002021-04-15
00850030203250SixFix Circular Fixation System176-113002021-04-15

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