ALEUTIAN Cervical SP-4255-07

GUDID 10888857515734

Trial, Size 11.5x14.5x11 mm, 7°

K2M, INC.

General internal orthopaedic fixation system implantation kit
Primary Device ID10888857515734
NIH Device Record Key9a19c6b3-7295-4f9c-b12e-a0a9c667596e
Commercial Distribution StatusIn Commercial Distribution
Brand NameALEUTIAN Cervical
Version Model NumberSP-4255-07
Catalog NumberSP-4255-07
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 Usefalse
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(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

Length11.5 Millimeter
Height11 Millimeter
Angle7 degree
Width14.5 Millimeter
Length11.5 Millimeter
Height11 Millimeter
Angle7 degree
Width14.5 Millimeter
Length11.5 Millimeter
Height11 Millimeter
Angle7 degree
Width14.5 Millimeter
Length11.5 Millimeter
Height11 Millimeter
Angle7 degree
Width14.5 Millimeter
Length11.5 Millimeter
Height11 Millimeter
Angle7 degree
Width14.5 Millimeter
Length11.5 Millimeter
Height11 Millimeter
Angle7 degree
Width14.5 Millimeter
Length11.5 Millimeter
Height11 Millimeter
Angle7 degree
Width14.5 Millimeter
Length11.5 Millimeter
Height11 Millimeter
Angle7 degree
Width14.5 Millimeter
Length11.5 Millimeter
Height11 Millimeter
Angle7 degree
Width14.5 Millimeter
Length11.5 Millimeter
Height11 Millimeter
Angle7 degree
Width14.5 Millimeter
Length11.5 Millimeter
Height11 Millimeter
Angle7 degree
Width14.5 Millimeter
Length11.5 Millimeter
Height11 Millimeter
Angle7 degree
Width14.5 Millimeter
Length11.5 Millimeter
Height11 Millimeter
Angle7 degree
Width14.5 Millimeter
Length11.5 Millimeter
Height11 Millimeter
Angle7 degree
Width14.5 Millimeter
Length11.5 Millimeter
Height11 Millimeter
Angle7 degree
Width14.5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS110888857515734 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral fusion device with bone graft, lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10888857515734]

Moist Heat or Steam Sterilization

[10888857515734]

Moist Heat or Steam Sterilization

[10888857515734]

Moist Heat or Steam Sterilization

[10888857515734]

Moist Heat or Steam Sterilization

[10888857515734]

Moist Heat or Steam Sterilization

[10888857515734]

Moist Heat or Steam Sterilization

[10888857515734]

Moist Heat or Steam Sterilization

[10888857515734]

Moist Heat or Steam Sterilization

[10888857515734]

Moist Heat or Steam Sterilization

[10888857515734]

Moist Heat or Steam Sterilization

[10888857515734]

Moist Heat or Steam Sterilization

[10888857515734]

Moist Heat or Steam Sterilization

[10888857515734]

Moist Heat or Steam Sterilization

[10888857515734]

Moist Heat or Steam Sterilization

[10888857515734]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-01-18
Device Publish Date2021-01-08

On-Brand Devices [ALEUTIAN Cervical]

10888857515888Rasp, Size 11.5x14.5x15 mm, 7°
10888857515871Rasp, Size 11.5x14.5x14 mm, 7°
10888857515864Rasp, Size 11.5x14.5x13 mm, 7°
10888857515857Rasp, Size 11.5x14.5x12 mm, 7°
10888857515840Rasp, Size 11.5x14.5x11 mm, 7°
10888857515833Rasp, Size 11.5x14.5x10 mm, 7°
10888857515826Rasp, Size 11.5x14.5x9 mm, 7°
10888857515819Rasp, Size 11.5x14.5x8 mm, 7°
10888857515802Rasp, Size 11.5x14.5x7 mm, 7°
10888857515796Rasp, Size 11.5x14.5x6 mm, 7°
10888857515789Rasp, Size 11.5x14.5x5 mm, 7°
10888857515772Trial, Size 11.5x14.5x15 mm, 7°
10888857515765Trial, Size 11.5x14.5x14 mm, 7°
10888857515758Trial, Size 11.5x14.5x13 mm, 7°
10888857515741Trial, Size 11.5x14.5x12 mm, 7°
10888857515734Trial, Size 11.5x14.5x11 mm, 7°
10888857515727Trial, Size 11.5x14.5x10 mm, 7°
10888857515710Trial, Size 11.5x14.5x9 mm, 7°
10888857515703Trial, Size 11.5x14.5x8 mm, 7°
10888857515697Trial, Size 11.5x14.5x7 mm, 7°
10888857515680Trial, Size 11.5x14.5x6 mm, 7°
10888857515673Trial, Size 11.5x14.5x5 mm, 7°
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