FDA.reportPublic FDA data

MIOT PLATING SYSTEM

Primary DI
18032937161027
Brand
MIOT PLATING SYSTEM
Company
ORTHOFIX SRL
Model
1
Catalog number
SP37912
Device description
MINI BOX STRAIGHT PLATE, EMPTY
Published
2018-04-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HRSPlate, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K051945000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K051945000MIOT PLATING SYSTEMOrthofix Srl2005-09-06HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18032937161027PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1803293716102718032937161027

GMDN Terms#

Term, Definition table
TermDefinition
Instrument trayA flat shallow vessel, usually with a raised rim, providing a suitable platform for containing many medical, usually surgical instruments and items. It is typically made of stainless steel and designed to fit into other devices, e.g., supply trolleys, storage systems and sterilizers; it is not dedicated to sterilization. This device may or may not be fitted with a lid or cover. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+0390456719000info@orthofix.it

Regulatory Flags#

DUNS number
438793622
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
18059015375831OrthoNext™ Platform System Software2.1ORTHONEXTSW2.12025-01-31
18059015375848OrthoNext™ Platform System Software1.1TLHEXMODULESW1.12025-01-31
18052469476444OrthoNext™ Platform System Software1.0TLHEXMODULESW2023-03-31
18052469476451OrthoNext™ Platform System Software1.0MYHEXPLANSW2023-03-31
18053340345675OrthoNext™ Platform System Software2.0ORTHONEXTSW2023-03-31
18053340345682OrthoNext™ Platform System Software1.1JPSMODULESW2023-03-31
18032568033229Surgical Instruments1136202026-07-23
18032568033236Surgical Instruments1136212026-07-23
18032568036008WRIST FIXATION SYSTEMS1360082026-07-23
18059015376838Fitbone Transport and Lengthening System199-600038172026-07-23
18059015376845Fitbone Transport and Lengthening System199-600038182026-07-23
18059015376852Fitbone Transport and Lengthening System199-600038192026-07-23
18059015376869Fitbone Transport and Lengthening System199-600038202026-07-23
18059015376876Fitbone Transport and Lengthening System199-600038212026-07-23
18059015376883Fitbone Transport and Lengthening System199-600038222026-07-23
18059015376890Fitbone Transport and Lengthening System199-600038232026-07-23
18059015376906Fitbone Transport and Lengthening System199-600038242026-07-23
18059015376913Fitbone Transport and Lengthening System199-600038252026-07-23
18059015376920Fitbone Transport and Lengthening System199-600038262026-07-23
18059015376937Fitbone Transport and Lengthening System199-600038272026-07-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809986483843CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-28
08809986483850CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-28
08809986483867CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-28
08809986483874CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-28
08809986483881CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-28
08809986483898CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-28
08809986483904CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-28
08809986483911CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-28
08809986483928CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-28
08809986484048CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-28
08809986484123CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-28
08809986484147CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-28
08809986484154CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-28
08809986484161CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-28
08809986484178CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-28
08809986484185CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-28
08809986484192CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-28
08809986484208CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-28
08809986484215CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-28
08809986484222CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-28
08809986484239CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-28
08809986484345CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-28
08809986484352CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-28
08809986484369CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-28
08809986484376CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-28
08809986484383CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-28
08809986484390CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-28
08809986484406CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-28
08809986484413CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-28
08809986484420CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-28