InCore Subtalar

GUDID 00817701029106

InCore Subtalar 5.5mm x 102mm Screw

Medartis Inc.

Orthopaedic bone screw, non-bioabsorbable, sterile
Primary Device ID00817701029106
NIH Device Record Keyae0a023f-a345-46c6-ad8c-4501fa5c74c4
Commercial Distribution StatusIn Commercial Distribution
Brand NameInCore Subtalar
Version Model NumberICSUB55102
Company DUNS192756786
Company NameMedartis Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100817701029106 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-09-29
Device Publish Date2023-01-31

On-Brand Devices [InCore Subtalar]

00817701029250InCore Subtalar Implant Bushing, Large
00817701029243InCore Subtalar Implant Bushing, Medium
00817701029236InCore Subtalar Implant Bushing, Small
00817701029229InCore Subtalar Drill Bushing, Large
00817701028833InCore Subtalar Replacement Compression Screw
00817701028826InCore Subtalar Replacement Compression Frame Left
00817701028819InCore Subtalar Replacement Compression Frame Right
00817701028802InCore Subtalar 5.6mm Drill Bit Disposable
00817701028796InCore Subtalar T25 Driver Disposable
00817701028789InCore Subtalar 8.0mm Post Drill Disposable
00817701028772InCore Subtalar Instrument Case Lid
00817701028765InCore Subtalar Instrument Case
00817701028741InCore Subtalar Depth Probe
00817701028734InCore Subtalar Removal Fastener
00817701028727InCore Subtalar Removal Slap Hammer
00817701028710InCore Subtalar Removal Drill Guide
00817701028703InCore Subtalar 5.6mm Drill Bit
00817701028697InCore Subtalar T25 Driver
00817701028680InCore Subtalar 8.0mm Post Drill
00817701028673InCore Subtalar Post Fastener
00817701028666InCore Subtalar Drill Bushing, Medium
00817701028659InCore Subtalar Drill Bushing, Small
00817701028642InCore Subtalar Targeting Guide Assembly Left
00817701028635InCore Subtalar Targeting Guide Assembly Right
00817701028628InCore Subtalar Post Guide Left
00817701028611InCore Subtalar Post Guide Right
00817701029298InCore Subtalar K-Wires, Sterile
00817701029144InCore Subtalar 5.5mm x 110mm Screw
00817701029137InCore Subtalar 5.5mm x 108mm Screw
00817701029120InCore Subtalar 5.5mm x 106mm Screw
00817701029113InCore Subtalar 5.5mm x 104mm Screw
00817701029106InCore Subtalar 5.5mm x 102mm Screw
00817701029090InCore Subtalar 5.5mm x 100mm Screw
00817701029083InCore Subtalar 5.5mm x 98mm Screw
00817701029076InCore Subtalar 5.5mm x 96mm Screw
00817701029069InCore Subtalar 5.5mm x 94mm Screw
00817701029052InCore Subtalar 5.5mm x 92mm Screw
00817701029045InCore Subtalar 5.5mm x 90mm Screw
00817701029038InCore Subtalar 5.5mm x 88mm Screw
00817701029021InCore Subtalar 5.5mm x 86mm Screw
00817701029014InCore Subtalar 5.5mm x 84mm Screw
00817701029007InCore Subtalar 5.5mm x 82mm Screw
00817701028994InCore Subtalar 5.5mm x 80mm Screw
00817701028987InCore Subtalar 5.5mm x 78mm Screw
00817701028970InCore Subtalar 5.5mm x 76mm Screw
00817701028963InCore Subtalar 5.5mm x 74mm Screw
00817701028956InCore Subtalar 5.5mm x 72mm Screw
00817701028949InCore Subtalar 5.5mm x 70mm Screw
00817701028932InCore Subtalar 5.5mm x 68mm Screw
00817701028925InCore Subtalar 5.5mm x 66mm Screw

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