FDA.reportPublic FDA data

DRACO

Primary DI
00841742122007
Brand
DRACO
Company
HNM TOTAL RECON LLC
Model
HTR-03-200302
Catalog number
HTR-03-200302
Device description
DRACO MetaFuse OpenWedge Plate, Ti - #3, L
Published
2017-12-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
K102688000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K102688000MERETE LOCKING BONE PLATE SYSTEM IIMerete Medical GmbH2010-12-03KTT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841742122007PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841742122007008417421220078417421220070841742122007

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic fixation plate, non-bioabsorbable, non-sterileA non-sterile implantable sheet of firm material intended to be attached to fractured long bone fragments with screws to bridge and stabilize the fracture gap, and shield the site from stress as the bone heals; the material is not chemically degraded or absorbed by natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is typically used to treat traumatic or pathological orthopaedic fractures; it may also be used to temporarily augment bone following a lengthening procedure, or for arthrodesis (joint fusion). This device is intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
080024940
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
00841742143774ORIONHTR-04-304812HTR-04-3048122020-11-18
00841742143781ORIONHTR-04-304914HTR-04-3049142020-11-18
00841742143798ORIONHTR-04-304116HTR-04-3041162020-11-18
00841742143804ORIONHTR-04-304218HTR-04-3042182020-11-18
00841742143811ORIONHTR-04-304320HTR-04-3043202020-11-18
00841742143828ORIONHTR-04-304422HTR-04-3044222020-11-18
00841742143835ORIONHTR-04-304524HTR-04-3045242020-11-18
00841742143842ORIONHTR-04-304626HTR-04-3046262020-11-18
00841742143859ORIONHTR-04-304728HTR-04-3047282020-11-18
00841742143866ORIONHTR-04-304830HTR-04-3048302020-11-18
00841742143873ORIONHTR-04-304932HTR-04-3049322020-11-18
00841742143880ORIONHTR-04-304134HTR-04-3041342020-11-18
00841742143897ORIONHTR-04-304236HTR-04-3042362020-11-18
00841742143903ORIONHTR-04-304338HTR-04-3043382020-11-18
00841742143910ORIONHTR-04-304440HTR-04-3044402020-11-18
00841742143927ORIONHTR-04-404514HTR-04-4045142020-11-18
00841742143934ORIONHTR-04-404616HTR-04-4046162020-11-18
00841742143941ORIONHTR-04-404718HTR-04-4047182020-11-18
00841742143958ORIONHTR-04-404820HTR-04-4048202020-11-18
00841742143965ORIONHTR-04-404922HTR-04-4049222020-11-18

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Primary DI, Brand, Company table
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