NIAGARA® Lateral Access System SP-4124-01

GUDID 10888857515000

Dilator, Size 8 mm

K2M, INC.

Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable
Primary Device ID10888857515000
NIH Device Record Keyf11f1ad0-c85d-461d-accf-3c026889f386
Commercial Distribution StatusIn Commercial Distribution
Brand NameNIAGARA® Lateral Access System
Version Model NumberSP-4124-01
Catalog NumberSP-4124-01
Company DUNS146060863
Company NameK2M, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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

Device Dimensions

Outer Diameter8 Millimeter
Outer Diameter8 Millimeter
Outer Diameter8 Millimeter
Outer Diameter8 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS110888857515000 [Primary]
GS110888857515000 [Primary]
GS110888857515000 [Primary]
GS110888857515000 [Primary]

FDA Product Code

LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10888857515000]

Moist Heat or Steam Sterilization


[10888857515000]

Moist Heat or Steam Sterilization


[10888857515000]

Moist Heat or Steam Sterilization


[10888857515000]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-11-10
Device Publish Date2020-11-02

On-Brand Devices [NIAGARA® Lateral Access System]

10888857468719Angled Blade, Size 13x290 mm
10888857468702Angled Blade, Size 13x240 mm
10888857468696Angled Blade, Size 8x290 mm
10888857468689Angled Blade, Size 8x240 mm
10888857468672Straight Blade, Size 13x290 mm
10888857468665Straight Blade, Size 13x240 mm
10888857468658Straight Blade, Size 8x290 mm
10888857468641Straight Blade, Size 8x240 mm
10888857488397Inner Dilator
10888857488076Offset Blade Left, Size 220 mm
10888857488069Offset Blade Left, Size 210 mm
10888857488052Offset Blade Left, Size 200 mm
10888857488045Offset Blade Left, Size 190 mm
10888857488038Offset Blade Left, Size 180 mm
10888857488021Offset Blade Left, Size 170 mm
10888857488014Offset Blade Left, Size 160 mm
10888857488007Offset Blade Left, Size 150 mm
10888857487994Offset Blade Left, Size 140 mm
10888857487987Offset Blade Left, Size 130 mm
10888857487970Offset Blade Left, Size 120 mm
10888857487963Offset Blade Left, Size 110 mm
10888857487956Offset Blade Left, Size 100 mm
10888857487949Offset Blade Left, Size 90 mm
10888857487932Offset Blade Left, Size 80 mm
10888857487925Offset Blade Right, Size 220 mm
10888857487918Offset Blade Right, Size 210 mm
10888857487901Offset Blade Right, Size 200 mm
10888857487895Offset Blade Right, Size 190 mm
10888857487888Offset Blade Right, Size 180 mm
10888857487871Offset Blade Right, Size 170 mm
10888857487864Offset Blade Right, Size 160 mm
10888857487857Offset Blade Right, Size 150 mm
10888857487840Offset Blade Right, Size 140 mm
10888857487833Offset Blade Right, Size 130 mm
10888857487826Offset Blade Right, Size 120 mm
10888857487819Offset Blade Right, Size 110 mm
10888857487802Offset Blade Right, Size 100 mm
10888857487796Offset Blade Right, Size 90 mm
10888857487789Offset Blade Right, Size 80 mm
10888857489882Intradiscal Shim, Size 30 mm
10888857488748Intradiscal Shim, Size 30 mm
10888857488731Intradiscal Shim, Size 20 mm
10888857488922Cranial Caudal Blade, Size 220 mm
10888857488915Cranial Caudal Blade, Size 210 mm
10888857488908Cranial Caudal Blade, Size 200 mm
10888857488892Cranial Caudal Blade, Size 190 mm
10888857488885Cranial Caudal Blade, Size 180 mm
10888857488878Cranial Caudal Blade, Size 170 mm
10888857488861Cranial Caudal Blade, Size 160 mm
10888857488854Cranial Caudal Blade, Size 150 mm

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