FDA.reportPublic FDA data

Revolution External Plating System

Primary DI
00854641008198
Brand
Revolution External Plating System
Company
Metalogix
Model
620030
Device description
Self Drill Half-Pin 5x30x215mm
Published
2019-08-07
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
K181630000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181630000Revolution External Plating SystemNew Standard Device Dba Metalogix2019-05-29KTT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00854641008198PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854641008198008546410081988546410081980854641008198

GMDN Terms#

Term, Definition table
TermDefinition
External orthopaedic fixation system, single-use, non-sterileAn assembly of non-sterile devices designed to stabilize fractured bones to promote treatment and healing. It typically consists of an external plastic and/or metallic fixator (a framework) and other external and/or implantable components such as clamps, rods, rings, pins, bolts, and nuts, as well as some reusable instrumentation (e.g., wrenches, depth gauge, tensioner). It is used mainly to help the healing of long bones such as the femur, tibia and humerus, as well as fractures of the foot and ankle, joint fusions, and limb lengthening. This is a single-use device intended to be sterilized prior to use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
833-653-2019elton@metalogix.life

Regulatory Flags#

DUNS number
080859336
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00854641008006Revolution External Plating System1004042019-08-07
00854641008013Revolution External Plating System9001032019-08-07
00854641008020Revolution External Plating System9001002019-08-07
00854641008037Revolution External Plating System9001052019-08-07
00854641008044Revolution External Plating System9001062019-08-07
00854641008051Revolution External Plating System900123-F2019-08-07
00854641008068Revolution External Plating System900124-F2019-08-07
00854641008075Revolution External Plating System900125-F2019-08-07
00854641008082Revolution External Plating System900126-F2019-08-07
00854641008099Revolution External Plating System900127-F2019-08-07
00854641008105Revolution External Plating System900128-F2019-08-07
00854641008112Revolution External Plating System9001042019-08-07
00854641008129Revolution External Plating System900129-F2019-08-07
00854641008136Revolution External Plating System6170152019-08-07
00854641008143Revolution External Plating System6170302019-08-07
00854641008150Revolution External Plating System6170502019-08-07
00854641008167Revolution External Plating System6180152019-08-07
00854641008174Revolution External Plating System6180302019-08-07
00854641008181Revolution External Plating System6180502019-08-07
00854641008204Revolution External Plating System6200402019-08-07

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Primary DI, Brand, Company table
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