CASCADIA Interbody System 8030-90207

GUDID 10888857554269

Untightening Ring Inserter

K2M, INC.

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Primary Device ID10888857554269
NIH Device Record Key2ec92dd9-55c7-4b0b-b4ac-92513b3dfeee
Commercial Distribution StatusIn Commercial Distribution
Brand NameCASCADIA Interbody System
Version Model Number8030-90207
Catalog Number8030-90207
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
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 Identifiers

Device Issuing AgencyDevice ID
GS110888857554269 [Primary]

FDA Product Code

LXHOrthopedic manual surgical instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10888857554269]

Moist Heat or Steam Sterilization


[10888857554269]

Moist Heat or Steam Sterilization


[10888857554269]

Moist Heat or Steam Sterilization


[10888857554269]

Moist Heat or Steam Sterilization


[10888857554269]

Moist Heat or Steam Sterilization


[10888857554269]

Moist Heat or Steam Sterilization


[10888857554269]

Moist Heat or Steam Sterilization


[10888857554269]

Moist Heat or Steam Sterilization


[10888857554269]

Moist Heat or Steam Sterilization


[10888857554269]

Moist Heat or Steam Sterilization


[10888857554269]

Moist Heat or Steam Sterilization


[10888857554269]

Moist Heat or Steam Sterilization


[10888857554269]

Moist Heat or Steam Sterilization


[10888857554269]

Moist Heat or Steam Sterilization


[10888857554269]

Moist Heat or Steam Sterilization


[10888857554269]

Moist Heat or Steam Sterilization


[10888857554269]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-01-12
Device Publish Date2024-01-04

On-Brand Devices [CASCADIA Interbody System]

10888857551817Inserter Inner Shaft
10888857551800Inserter Outer Shaft
10888857462168ALIF Trial Inserter
10888857431461Tapered Driver Size 20
10888857383838Inserter Blade Tether
10888857383821Plate Assembly Final Tightener
10888857383715Plate Assembly Driver Tapered
10888857320673Graft Contaiment Ramp Size 22 mm, Stop
10888857272170Implant Inserter
10888857562943Caddy
10888857562936Caddy
10888857562929Caddy
10888857562912Caddy
10888857557277Inserter ATP, 35°
10888857557260Inserter ATP, 25°
10888857556072Inserter Inner Shaft ATP
10888857554269Untightening Ring Inserter

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