FDA.reportPublic FDA data

DRACO

Primary DI
00841742122502
Brand
DRACO
Company
HNM TOTAL RECON LLC
Model
HTR-03-400512
Catalog number
HTR-03-400512
Device description
DRACO MetaFuse Calcaneus Offset Plate, Ti - #12
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
HRSPlate, Fixation, Bone

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K120787000
K171624000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K120787000MERETE LOCKING BONE PLATE SYSTEM IIIMerete Medical GmbH2012-11-27HRS
K171624000IXOS Radius Plate SystemStuckenbrock Medizintechnik GmbH2018-03-29HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841742122502PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841742122502008417421225028417421225020841742122502

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08904255300064ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300071ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
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08904255300095ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300101ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300118ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300125ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300132ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300149ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300156ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
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08904255300170ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
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08904255300194ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300200ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
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08904255300224ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300231ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300248ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300255ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300262ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300705ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300712ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300729ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300736ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300743ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300750ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300767ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300774ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300781ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18