YUKON OCT Spinal System 7601-04020M

GUDID 10888857350397

Polyaxial Screw ML, Size Ø4.0x20 mm

K2M, INC.

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID10888857350397
NIH Device Record Keyb3066d30-344e-4c2f-b8fd-0d6bcfc6ff71
Commercial Distribution StatusIn Commercial Distribution
Brand NameYUKON OCT Spinal System
Version Model Number7601-04020M
Catalog Number7601-04020M
Company DUNS146060863
Company NameK2M, 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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(703)777-3155
Emailsgilbert@k2m.com
Phone+1(703)777-3155
Emailsgilbert@k2m.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com

Device Dimensions

Length20 Millimeter
Outer Diameter4 Millimeter
Length20 Millimeter
Outer Diameter4 Millimeter
Length20 Millimeter
Outer Diameter4 Millimeter
Length20 Millimeter
Outer Diameter4 Millimeter
Length20 Millimeter
Outer Diameter4 Millimeter
Length20 Millimeter
Outer Diameter4 Millimeter
Length20 Millimeter
Outer Diameter4 Millimeter
Length20 Millimeter
Outer Diameter4 Millimeter
Length20 Millimeter
Outer Diameter4 Millimeter
Length20 Millimeter
Outer Diameter4 Millimeter
Length20 Millimeter
Outer Diameter4 Millimeter
Length20 Millimeter
Outer Diameter4 Millimeter
Length20 Millimeter
Outer Diameter4 Millimeter
Length20 Millimeter
Outer Diameter4 Millimeter
Length20 Millimeter
Outer Diameter4 Millimeter
Length20 Millimeter
Outer Diameter4 Millimeter
Length20 Millimeter
Outer Diameter4 Millimeter
Length20 Millimeter
Outer Diameter4 Millimeter
Length20 Millimeter
Outer Diameter4 Millimeter
Length20 Millimeter
Outer Diameter4 Millimeter
Length20 Millimeter
Outer Diameter4 Millimeter
Length20 Millimeter
Outer Diameter4 Millimeter
Length20 Millimeter
Outer Diameter4 Millimeter
Length20 Millimeter
Outer Diameter4 Millimeter
Length20 Millimeter
Outer Diameter4 Millimeter
Length20 Millimeter
Outer Diameter4 Millimeter
Length20 Millimeter
Outer Diameter4 Millimeter
Length20 Millimeter
Outer Diameter4 Millimeter
Length20 Millimeter
Outer Diameter4 Millimeter
Length20 Millimeter
Outer Diameter4 Millimeter
Length20 Millimeter
Outer Diameter4 Millimeter
Length20 Millimeter
Outer Diameter4 Millimeter
Length20 Millimeter
Outer Diameter4 Millimeter
Length20 Millimeter
Outer Diameter4 Millimeter
Length20 Millimeter
Outer Diameter4 Millimeter
Length20 Millimeter
Outer Diameter4 Millimeter
Length20 Millimeter
Outer Diameter4 Millimeter
Length20 Millimeter
Outer Diameter4 Millimeter
Length20 Millimeter
Outer Diameter4 Millimeter
Length20 Millimeter
Outer Diameter4 Millimeter
Length20 Millimeter
Outer Diameter4 Millimeter
Length20 Millimeter
Outer Diameter4 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS110888857350397 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10888857350397]

Moist Heat or Steam Sterilization

[10888857350397]

Moist Heat or Steam Sterilization

[10888857350397]

Moist Heat or Steam Sterilization

[10888857350397]

Moist Heat or Steam Sterilization

[10888857350397]

Moist Heat or Steam Sterilization

[10888857350397]

Moist Heat or Steam Sterilization

[10888857350397]

Moist Heat or Steam Sterilization

[10888857350397]

Moist Heat or Steam Sterilization

[10888857350397]

Moist Heat or Steam Sterilization

[10888857350397]

Moist Heat or Steam Sterilization

[10888857350397]

Moist Heat or Steam Sterilization

[10888857350397]

Moist Heat or Steam Sterilization

[10888857350397]

Moist Heat or Steam Sterilization

[10888857350397]

Moist Heat or Steam Sterilization

[10888857350397]

Moist Heat or Steam Sterilization

[10888857350397]

Moist Heat or Steam Sterilization

[10888857350397]

Moist Heat or Steam Sterilization

[10888857350397]

Moist Heat or Steam Sterilization

[10888857350397]

Moist Heat or Steam Sterilization

[10888857350397]

Moist Heat or Steam Sterilization

[10888857350397]

Moist Heat or Steam Sterilization

[10888857350397]

Moist Heat or Steam Sterilization

[10888857350397]

Moist Heat or Steam Sterilization

[10888857350397]

Moist Heat or Steam Sterilization

[10888857350397]

Moist Heat or Steam Sterilization

[10888857350397]

Moist Heat or Steam Sterilization

[10888857350397]

Moist Heat or Steam Sterilization

[10888857350397]

Moist Heat or Steam Sterilization

[10888857350397]

Moist Heat or Steam Sterilization

[10888857350397]

Moist Heat or Steam Sterilization

[10888857350397]

Moist Heat or Steam Sterilization

[10888857350397]

Moist Heat or Steam Sterilization

[10888857350397]

Moist Heat or Steam Sterilization

[10888857350397]

Moist Heat or Steam Sterilization

[10888857350397]

Moist Heat or Steam Sterilization

[10888857350397]

Moist Heat or Steam Sterilization

[10888857350397]

Moist Heat or Steam Sterilization

[10888857350397]

Moist Heat or Steam Sterilization

[10888857350397]

Moist Heat or Steam Sterilization

[10888857350397]

Moist Heat or Steam Sterilization

[10888857350397]

Moist Heat or Steam Sterilization

[10888857350397]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-08-25

On-Brand Devices [YUKON OCT Spinal System]

10888857398344Axial Rod Connector, Size Ø3.5 mm/Ø5.5/6.0 mm
10888857398337Parallel Rod Connector, Size Ø3.5-Ø5.5/6.0 mm, 4 Screw
10888857398320Lateral Offset Connector, Size 30 mm Angled
10888857398313Lateral Offset Connector, Size 25 mm Angled
10888857398306Lateral Offset Connector, Size 20 mm Angled
10888857398290Lateral Offset Connector, Size 15 mm Angled
10888857398283Lateral Offset Connector, Size 10 mm Angled
10888857398276Contoured Rod, Size Ø4.0x120 mm CoCr
10888857398269Contoured Rod, Size Ø4.0x115 mm CoCr
10888857398252Contoured Rod, Size Ø4.0x110 mm CoCr
10888857398245Contoured Rod, Size Ø4.0x105 mm CoCr
10888857398238Contoured Rod, Size Ø4.0x100 mm CoCr
10888857398221Contoured Rod, Size Ø4.0x95 mm CoCr
10888857398214Contoured Rod, Size Ø4.0x90 mm CoCr
10888857398207Contoured Rod, Size Ø4.0x85 mm CoCr
10888857398191Contoured Rod, Size Ø4.0x80 mm CoCr
10888857398184Contoured Rod, Size Ø4.0x75 mm CoCr
10888857398177Contoured Rod, Size Ø4.0x70 mm CoCr
10888857398160Contoured Rod, Size Ø4.0x65 mm CoCr
10888857398153Contoured Rod, Size Ø4.0x60 mm CoCr
10888857398146Contoured Rod, Size Ø4.0x55 mm CoCr
10888857398139Contoured Rod, Size Ø4.0x50 mm CoCr
10888857398122Contoured Rod, Size Ø4.0x45 mm CoCr
10888857398115Contoured Rod, Size Ø4.0x40 mm CoCr
10888857398108Contoured Rod, Size Ø4.0x35 mm CoCr
10888857398092Contoured Rod, Size Ø4.0x30 mm CoCr
10888857398085Contoured Rod, Size Ø4.0x25 mm CoCr
10888857398078Contoured Rod, Size Ø3.5x120 mm CoCr
10888857398061Contoured Rod, Size Ø3.5x115 mm CoCr
10888857398054Contoured Rod, Size Ø3.5x110 mm CoCr
10888857398047Contoured Rod, Size Ø3.5x105 mm CoCr
10888857398030Contoured Rod, Size Ø3.5x100 mm CoCr
10888857398023Contoured Rod, Size Ø3.5x95 mm CoCr
10888857398016Contoured Rod, Size Ø3.5x90 mm CoCr
10888857398009Contoured Rod, Size Ø3.5x85 mm CoCr
10888857397996Contoured Rod, Size Ø3.5x80 mm CoCr
10888857397989Contoured Rod, Size Ø3.5x75 mm CoCr
10888857397972Contoured Rod, Size Ø3.5x70 mm CoCr
10888857397965Contoured Rod, Size Ø3.5x65 mm CoCr
10888857397958Contoured Rod, Size Ø3.5x60 mm CoCr
10888857397941Contoured Rod, Size Ø3.5x55 mm CoCr
10888857397934Contoured Rod, Size Ø3.5x50 mm CoCr
10888857397927Contoured Rod, Size Ø3.5x45 mm CoCr
10888857397910Contoured Rod, Size Ø3.5x40 mm CoCr
10888857397903Contoured Rod, Size Ø3.5x35 mm CoCr
10888857397897Contoured Rod, Size Ø3.5x30 mm CoCr
10888857397880Contoured Rod, Size Ø3.5x25 mm CoCr
10888857397873Contoured Rod, Size Ø4.0x120 mm
10888857397866Contoured Rod, Size Ø4.0x115 mm
10888857397859Contoured Rod, Size Ø4.0x110 mm
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