CHESAPEAKE® Stabilization System 2013-21940L25

GUDID 10888857157118

Implant

K2M, INC.

Vertebral body prosthesis, non-sterile
Primary Device ID10888857157118
NIH Device Record Keya956cd73-b2c3-4405-be39-fe7fcba53d4d
Commercial Distribution StatusIn Commercial Distribution
Brand NameCHESAPEAKE® Stabilization System
Version Model Number2013-21940L25
Catalog Number2013-21940L25
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

Device Dimensions

Width40 Millimeter
Height19 Millimeter
Angle25 degree
Length30 Millimeter
Width40 Millimeter
Height19 Millimeter
Angle25 degree
Length30 Millimeter
Width40 Millimeter
Height19 Millimeter
Angle25 degree
Length30 Millimeter
Width40 Millimeter
Height19 Millimeter
Angle25 degree
Length30 Millimeter
Width40 Millimeter
Height19 Millimeter
Angle25 degree
Length30 Millimeter
Width40 Millimeter
Height19 Millimeter
Angle25 degree
Length30 Millimeter
Width40 Millimeter
Height19 Millimeter
Angle25 degree
Length30 Millimeter
Width40 Millimeter
Height19 Millimeter
Angle25 degree
Length30 Millimeter
Width40 Millimeter
Height19 Millimeter
Angle25 degree
Length30 Millimeter
Width40 Millimeter
Height19 Millimeter
Angle25 degree
Length30 Millimeter
Width40 Millimeter
Height19 Millimeter
Angle25 degree
Length30 Millimeter
Width40 Millimeter
Height19 Millimeter
Angle25 degree
Length30 Millimeter
Width40 Millimeter
Height19 Millimeter
Angle25 degree
Length30 Millimeter
Width40 Millimeter
Height19 Millimeter
Angle25 degree
Length30 Millimeter
Width40 Millimeter
Height19 Millimeter
Angle25 degree
Length30 Millimeter
Width40 Millimeter
Height19 Millimeter
Angle25 degree
Length30 Millimeter
Width40 Millimeter
Height19 Millimeter
Angle25 degree
Length30 Millimeter
Width40 Millimeter
Height19 Millimeter
Angle25 degree
Length30 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS110888857157118 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OVDIntervertebral fusion device with integrated fixation, lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10888857157118]

Moist Heat or Steam Sterilization

[10888857157118]

Moist Heat or Steam Sterilization

[10888857157118]

Moist Heat or Steam Sterilization

[10888857157118]

Moist Heat or Steam Sterilization

[10888857157118]

Moist Heat or Steam Sterilization

[10888857157118]

Moist Heat or Steam Sterilization

[10888857157118]

Moist Heat or Steam Sterilization

[10888857157118]

Moist Heat or Steam Sterilization

[10888857157118]

Moist Heat or Steam Sterilization

[10888857157118]

Moist Heat or Steam Sterilization

[10888857157118]

Moist Heat or Steam Sterilization

[10888857157118]

Moist Heat or Steam Sterilization

[10888857157118]

Moist Heat or Steam Sterilization

[10888857157118]

Moist Heat or Steam Sterilization

[10888857157118]

Moist Heat or Steam Sterilization

[10888857157118]

Moist Heat or Steam Sterilization

[10888857157118]

Moist Heat or Steam Sterilization

[10888857157118]

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 [CHESAPEAKE® Stabilization System]

10888857404403T-Handle Tightener
10888857404397Inner Shaft
10888857404380Implant Inserter
10888857385795Single Barrel Drill Guide
10888857381537Adjustable Inserter
10888857320895Modular Anterior Insertion Ramp, Size Insertion Ramp
10888857295902Drill Guide, Size 8 mm
10888857295896Drill Guide, Size 7 mm
10888857271371Screw, Self Starting, Size Ø5.5x35 mm
10888857271364Screw, Self Starting, Size Ø5.5x15 mm
10888857271357Screw, Self Starting, Size Ø5.5x30 mm
10888857271340Screw, Self Starting, Size Ø5.5x25 mm
10888857271333Screw, Self Starting, Size Ø5.5x20 mm
10888857243453Drill Guide Inserter
10888857198579Removal Tool
10888857181274Expandable Drill Guide, Size 21 mm
10888857181267Expandable Drill Guide, Size 19 mm
10888857181250Expandable Drill Guide, Size 17 mm
10888857181243Expandable Drill Guide, Size 15 mm
10888857181236Expandable Drill Guide, Size 13 mm
10888857181229Expandable Drill Guide, Size 11 mm
10888857157248Implant
10888857157231Implant
10888857157224Implant
10888857157217Implant, Size 28x36x21 mm, 30°
10888857157200Implant, Size 28x36x21 mm, 25°
10888857157194Implant, Size 28x36x21 mm, 20°
10888857157187Implant, Size 30x40x20 mm, 30°
10888857157170Implant, Size 30x40x20 mm, 25°
10888857157163Implant, Size 30x40x20 mm, 20°
10888857157156Implant, Size 28x36x20 mm, 30°
10888857157149Implant, Size 28x36x20 mm, 25°
10888857157132Implant, Size 28x36x20 mm, 20°
10888857157125Implant
10888857157118Implant
10888857157101Implant
10888857157095Implant
10888857157088Implant
10888857157071Implant
10888857157064Implant, Size 30x40x18 mm, 30°
10888857157057Implant, Size 30x40x18 mm, 25°
10888857157040Implant, Size 30x40x18 mm, 20°
10888857157033Implant, Size 28x36x18 mm, 30°
10888857157026Implant, Size 28x36x18 mm, 25°
10888857157019Implant, Size 28x36x18 mm, 20°
10888857157002Implant
10888857156999Implant
10888857156982Implant
10888857156975Implant
10888857156968Implant

Trademark Results [CHESAPEAKE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CHESAPEAKE
CHESAPEAKE
98839831 not registered Live/Pending
Chesapeake Plywood, LLC
2024-11-06
CHESAPEAKE
CHESAPEAKE
98625066 not registered Live/Pending
Molly's IP Holding LLC
2024-06-28
CHESAPEAKE
CHESAPEAKE
97837642 not registered Live/Pending
Samsonite IP Holdings S.à r.l.
2023-03-14
CHESAPEAKE
CHESAPEAKE
97682449 not registered Live/Pending
ACME PAPER & SUPPLY CO., INC.
2022-11-17
CHESAPEAKE
CHESAPEAKE
97682408 not registered Live/Pending
ACME PAPER & SUPPLY CO., INC.
2022-11-17
CHESAPEAKE
CHESAPEAKE
97682337 not registered Live/Pending
ACME PAPER & SUPPLY CO., INC.
2022-11-17
CHESAPEAKE
CHESAPEAKE
97682270 not registered Live/Pending
ACME PAPER & SUPPLY CO., INC.
2022-11-17
CHESAPEAKE
CHESAPEAKE
97243823 not registered Live/Pending
Bath Authority LLC
2022-01-28
CHESAPEAKE
CHESAPEAKE
90511067 not registered Live/Pending
Chesapeake Companies, Inc.
2021-02-04
CHESAPEAKE
CHESAPEAKE
88039955 5690417 Live/Registered
Chesapeake Kitchen Wholesalers, Inc.
2018-07-16
CHESAPEAKE
CHESAPEAKE
87910004 not registered Live/Pending
J.J. Haines & Company, Inc.
2018-05-07
CHESAPEAKE
CHESAPEAKE
86981854 5183277 Live/Registered
ACME PAPER & SUPPLY CO., INC.
2015-08-17
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