FDA.report

Revolution External Plating System

Primary DI
00854641008341
Brand
Revolution External Plating System
Company
Metalogix
Model
623060
Device description
Blunt Half-Pin 6x60x215mm
Published
2019-08-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Product Code Classifications

CodeDeviceSpecialtyClass
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentOrthopedic2

Premarket Submissions

SubmissionSupplement
K181630000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K181630000Revolution External Plating SystemNew Standard Device Dba Metalogix2019-05-29KTT

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00854641008341PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00854641008341008546410083418546410083410854641008341

GMDN Terms

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

TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
833-653-2019elton@metalogix.life

Regulatory Flags

DUNS number
080859336
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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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
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00854641008181Revolution External Plating System6180502019-08-07
00854641008198Revolution External Plating System6200302019-08-07

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