AOS CLAVICLE INTRAMEDULLARY DEVICE 3.5mm x 120mm

Primary DI
00848665021233
Brand
AOS CLAVICLE INTRAMEDULLARY DEVICE 3.5mm x 120mm
Company
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
Model
1300-120
Published
2015-10-27
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
HSBRod, Fixation, Intramedullary And Accessories
JDWPin, Fixation, Threaded

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSBRod, Fixation, Intramedullary And AccessoriesOrthopedic2
JDWPin, Fixation, ThreadedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K143204000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143204000AOS Clavicle Intramedullary DeviceAdvanced Orthopaedic Solutions, Inc.2015-06-03HSB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00848665021233PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848665021233008486650212338486650212330848665021233

GMDN Terms#

Term, Definition table
TermDefinition
Clavicle fixation pinA small-diameter rod used for the fixation of a bone fracture or bone grafts, an osteotomy, or an arthrodesis, in the presence of additional immobilization, typically to treat midshaft fractures, nonunions, and malunions of the clavicle bone. The rod may be smooth or partially-threaded and may be fitted with a securing nut and is capable of being fitted into the intramedullary canal of the clavicle through a small incision. It is typically made of surgical stainless steel. This is a single-use device.

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

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