AOS THREADED HALF PIN (AO STYLE) 2.0mm x 75mm x 10mm

Primary DI
00848665022292
Brand
AOS THREADED HALF PIN (AO STYLE) 2.0mm x 75mm x 10mm
Company
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
Model
1410-075
Published
2015-10-28
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
JDWPin, Fixation, Threaded
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDWPin, Fixation, ThreadedOrthopedic2
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141912000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141912000AOS SMALL BONE EXTERNAL FIXATION, THREADED HALF PINS, AOS SMALL BONE EXTERNAL FIXATION, CARBON FIBER RODS, AOS SMALL BONAdvanced Orthopaedic Solutions, Inc.2014-10-29KTT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00848665022292PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848665022292008486650222928486650222920848665022292

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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
117858154
Device count
1
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00848665004021AOS CAPTURED BULLET TIP END CAP, TROCHANTERIC NAIL 1mmS1047-0192015-12-02
00848665004052AOS CAPTURED BULLET TIP END CAP, TROCHANTERIC NAIL 5mmS1047-0592015-12-02
00848665004083AOS CAPTURED BULLET TIP END CAP, TROCHANTERIC NAIL 10mmS1047-1092015-12-02
00848665004106AOS CAPTURED END CAP WITH POST 1mmS1048-0192015-12-02
00848665004823AOS END CAP, HUMERAL NAIL 2mmS1074-0202015-12-04
00848665004830AOS END CAP, HUMERAL NAIL 5mmS1074-0502015-12-05
00848665005332AOS END CAP, TIBIAL NAIL 5mmS1115-0502015-12-15
00848665005349AOS END CAP, TIBIAL NAIL 10mmS1115-1002015-12-15
00848665005356AOS END CAP, TIBIAL NAIL COMPRESSIONS11162015-12-15
00848665005363AOS SPACER, STATIC LOCKING TIBIAL NAILS11172015-10-14
00848665005745AOS FRACTURE REDUCTION SCREW HUMERAL NAILS11752015-10-12
00848665012521AOS END CAP, ANTEGRADE FEMORAL NAIL 5.0mmS1322-0052015-10-19
00848665012538AOS END CAP, ANTEGRADE FEMORAL NAIL 10.0mmS1322-0102015-12-18
00848665012545AOS END CAP, ANTEGRADE FEMORAL NAIL 15.0mmS1322-0152015-12-18
00848665012552AOS LOCKING END CAP, ANTEGRADE FEMORAL NAIL 0mmS13232015-12-18
00848665012569AOS END CAP, ANTEGRADE FEMORAL NAIL 0mmS13242015-12-18
00848665012576AOS SCREW SPACER/COMPRESSION BOLT S13262015-12-18
00848665013832AOS SET SCREW, A/R S10852015-12-04
00848665016536AOS END CAP, TIBIAL NAIL 5mm1115-0502015-10-26
00848665016543AOS END CAP, TIBIAL NAIL 10mm1115-1002015-10-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08032909624263ST.A.R. 90 F4CITIEFFE SRLKTT2024-09-11
08032909624270ST.A.R. 90 F4CITIEFFE SRLKTT2024-09-11
08032909624317ST.A.R. 90 F4CITIEFFE SRLKTT2024-07-19
08032909624355ST.A.R. 90 F4CITIEFFE SRLKTT2024-07-19
08032909624362ST.A.R. 90 F4CITIEFFE SRLKTT2024-07-19
08032909627639DOLPHIXCITIEFFE SRLKTT2020-01-10
08051739531237DOLPHIXCITIEFFE SRLJDW2019-05-18
08051739531244DOLPHIXCITIEFFE SRLKTT2019-05-18
08051739531251DOLPHIXCITIEFFE SRLJDW2019-05-18
08051739531725DOLPHIXCITIEFFE SRLKTT2019-01-09
08051739531725DOLPHIXCITIEFFE SRLJDW2019-01-09
08051739531732DOLPHIXCITIEFFE SRLKTT2019-01-09
08051739531732DOLPHIXCITIEFFE SRLJDW2019-01-09
08051739531749DOLPHIXCITIEFFE SRLJDW2019-01-09
08051739531749DOLPHIXCITIEFFE SRLKTT2019-01-09
08051739531756DOLPHIXCITIEFFE SRLKTT2018-12-15
08051739531756DOLPHIXCITIEFFE SRLJDW2018-12-15
08051739531763DOLPHIXCITIEFFE SRLKTT2018-12-15
08051739531763DOLPHIXCITIEFFE SRLJDW2018-12-15
08051739531770DOLPHIXCITIEFFE SRLKTT2018-12-15
08051739531770DOLPHIXCITIEFFE SRLJDW2018-12-15
08051739531787DOLPHIXCITIEFFE SRLJDW2018-12-15
08051739531787DOLPHIXCITIEFFE SRLKTT2018-12-15
08051739531268DOLPHIXCITIEFFE SRLJDW2018-10-17
08051739531268DOLPHIXCITIEFFE SRLKTT2018-10-17
08051739531275DOLPHIXCITIEFFE SRLKTT2018-10-17
08051739531275DOLPHIXCITIEFFE SRLJDW2018-10-17
08051739531282DOLPHIXCITIEFFE SRLKTT2018-10-17