ARI™ Anterior Staple System 1801-W0000

GUDID 10888857025196

Washer

K2M, INC.

Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use
Primary Device ID10888857025196
NIH Device Record Keyfdf47211-5210-4b59-a4eb-a5bd57526cd2
Commercial Distribution StatusIn Commercial Distribution
Brand NameARI™ Anterior Staple System
Version Model Number1801-W0000
Catalog Number1801-W0000
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

Device Identifiers

Device Issuing AgencyDevice ID
GS110888857025196 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MNHOrthosis, spondylolisthesis spinal fixation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10888857025196]

Moist Heat or Steam Sterilization


[10888857025196]

Moist Heat or Steam Sterilization


[10888857025196]

Moist Heat or Steam Sterilization


[10888857025196]

Moist Heat or Steam Sterilization


[10888857025196]

Moist Heat or Steam Sterilization


[10888857025196]

Moist Heat or Steam Sterilization


[10888857025196]

Moist Heat or Steam Sterilization


[10888857025196]

Moist Heat or Steam Sterilization


[10888857025196]

Moist Heat or Steam Sterilization


[10888857025196]

Moist Heat or Steam Sterilization


[10888857025196]

Moist Heat or Steam Sterilization


[10888857025196]

Moist Heat or Steam Sterilization


[10888857025196]

Moist Heat or Steam Sterilization


[10888857025196]

Moist Heat or Steam Sterilization


[10888857025196]

Moist Heat or Steam Sterilization


[10888857025196]

Moist Heat or Steam Sterilization


[10888857025196]

Moist Heat or Steam Sterilization


[10888857025196]

Moist Heat or Steam Sterilization


[10888857025196]

Moist Heat or Steam Sterilization


[10888857025196]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-09-24

On-Brand Devices [ARI™ Anterior Staple System]

10888857025196Washer
10888857025189Dual Hole Staple (Right)
10888857025172Dual Hole Staple (Left)
10888857025165Dual Hole Staple (Right)
10888857025158Dual Hole Staple (Left)
10888857025141Dual Hole Staple (Right)
10888857025134Dual Hole Staple (Left)
10888857025127Single Hole Staple
10888857025110Single Hole Staple

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