SAHARA™ Stabilization System 5808-22040L5

GUDID 10888857213814

Expandable ALIF, Size 30x40x20 mm, 5°

K2M, INC.

Vertebral body prosthesis, non-sterile Vertebral body prosthesis, non-sterile Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis
Primary Device ID10888857213814
NIH Device Record Keycc569ea6-ad20-4f22-8c53-d9cad2315637
Commercial Distribution StatusIn Commercial Distribution
Brand NameSAHARA™ Stabilization System
Version Model Number5808-22040L5
Catalog Number5808-22040L5
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

Depth30 Millimeter
Height20 Millimeter
Width40 Millimeter
Angle5 degree
Depth30 Millimeter
Height20 Millimeter
Width40 Millimeter
Angle5 degree
Depth30 Millimeter
Height20 Millimeter
Width40 Millimeter
Angle5 degree
Depth30 Millimeter
Height20 Millimeter
Width40 Millimeter
Angle5 degree
Depth30 Millimeter
Height20 Millimeter
Width40 Millimeter
Angle5 degree
Depth30 Millimeter
Height20 Millimeter
Width40 Millimeter
Angle5 degree
Depth30 Millimeter
Height20 Millimeter
Width40 Millimeter
Angle5 degree
Depth30 Millimeter
Height20 Millimeter
Width40 Millimeter
Angle5 degree
Depth30 Millimeter
Height20 Millimeter
Width40 Millimeter
Angle5 degree
Depth30 Millimeter
Height20 Millimeter
Width40 Millimeter
Angle5 degree
Depth30 Millimeter
Height20 Millimeter
Width40 Millimeter
Angle5 degree
Depth30 Millimeter
Height20 Millimeter
Width40 Millimeter
Angle5 degree
Depth30 Millimeter
Height20 Millimeter
Width40 Millimeter
Angle5 degree
Depth30 Millimeter
Height20 Millimeter
Width40 Millimeter
Angle5 degree
Depth30 Millimeter
Height20 Millimeter
Width40 Millimeter
Angle5 degree
Depth30 Millimeter
Height20 Millimeter
Width40 Millimeter
Angle5 degree
Depth30 Millimeter
Height20 Millimeter
Width40 Millimeter
Angle5 degree
Depth30 Millimeter
Height20 Millimeter
Width40 Millimeter
Angle5 degree

Device Identifiers

Device Issuing AgencyDevice ID
GS110888857213814 [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

[10888857213814]

Moist Heat or Steam Sterilization

[10888857213814]

Moist Heat or Steam Sterilization

[10888857213814]

Moist Heat or Steam Sterilization

[10888857213814]

Moist Heat or Steam Sterilization

[10888857213814]

Moist Heat or Steam Sterilization

[10888857213814]

Moist Heat or Steam Sterilization

[10888857213814]

Moist Heat or Steam Sterilization

[10888857213814]

Moist Heat or Steam Sterilization

[10888857213814]

Moist Heat or Steam Sterilization

[10888857213814]

Moist Heat or Steam Sterilization

[10888857213814]

Moist Heat or Steam Sterilization

[10888857213814]

Moist Heat or Steam Sterilization

[10888857213814]

Moist Heat or Steam Sterilization

[10888857213814]

Moist Heat or Steam Sterilization

[10888857213814]

Moist Heat or Steam Sterilization

[10888857213814]

Moist Heat or Steam Sterilization

[10888857213814]

Moist Heat or Steam Sterilization

[10888857213814]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-12-02

On-Brand Devices [SAHARA™ Stabilization System]

10888857381728Footprint Trial, 30x40 mm, Tapered
10888857381711Footprint Trial, 28x36 mm, Tapered
10888857381704Footprint Trial, 24x30 mm, Tapered
10888857213814Expandable ALIF, Size 30x40x20 mm, 5°
10888857213807Expandable ALIF, Size 30x40x20 mm, 15°
10888857213791Expandable ALIF, Size 30x40x20 mm, 10°
10888857213784Expandable ALIF, Size 28x36x20 mm, 5°
10888857213777Expandable ALIF, Size 28x36x20 mm, 15°
10888857213760Expandable ALIF, Size 28x36x20 mm, 10°
10888857213753Expandable ALIF, Size 24x30x20 mm, 5°
10888857213746Expandable ALIF, Size 24x30x20 mm, 15°
10888857213739Expandable ALIF, Size 24x30x20 mm, 10°
10888857213722Expandable ALIF, Size 30x40x19 mm, 5°
10888857213715Expandable ALIF, Size 30x40x19 mm, 15°
10888857213708Expandable ALIF, Size 30x40x19 mm, 10°
10888857213692Expandable ALIF, Size 28x36x19 mm, 5°
10888857213685Expandable ALIF, Size 28x36x19 mm, 15°
10888857213678Expandable ALIF, Size 28x36x19 mm, 10°
10888857213661Expandable ALIF, Size 24x30x19 mm, 5°
10888857213654Expandable ALIF, Size 24x30x19 mm, 15°
10888857213647Expandable ALIF, Size 24x30x19 mm, 10°
10888857213630Expandable ALIF, Size 30x40x18 mm, 5°
10888857213623Expandable ALIF, Size 30x40x18 mm, 15°
10888857213616Expandable ALIF, Size 30x40x18 mm, 10°
10888857213609Expandable ALIF, Size 28x36x18 mm, 5°
10888857213593Expandable ALIF, Size 28x36x18 mm, 15°
10888857213586Expandable ALIF, Size 28x36x18 mm, 10°
10888857213579Expandable ALIF, Size 24x30x18 mm, 5°
10888857213562Expandable ALIF, Size 24x30x18 mm, 15°
10888857213555Expandable ALIF, Size 24x30x18 mm, 10°
10888857213548Expandable ALIF Size 30x40x17 mm, 5°
10888857213531Expandable ALIF Size 30x40x17 mm, 15°
10888857213524Expandable ALIF Size 30x40x17 mm, 10°
10888857213517Expandable ALIF Size 28x36x17 mm, 5°
10888857213500Expandable ALIF Size 28x36x17 mm, 15°
10888857213494Expandable ALIF Size 28x36x17 mm, 10°
10888857213487Expandable ALIF Size 24x30x17 mm, 5°
10888857213470Expandable ALIF Size 24x30x17 mm, 15°
10888857213463Expandable ALIF Size 24x30x17 mm, 10°
10888857213456Expandable ALIF, Size 30x40x16 mm, 5°
10888857213449Expandable ALIF Size 30x40x16 mm, 15°
10888857213432Expandable ALIF, Size 30x40x16 mm, 10°
10888857213425Expandable ALIF, Size 28x36x16 mm, 5°
10888857213418Expandable ALIF Size 28x36x16 mm, 15°
10888857213401Expandable ALIF, Size 28x36x16 mm, 10°
10888857213395Expandable ALIF, Size 24x30x16 mm, 5°
10888857213388Expandable ALIF Size 24x30x16 mm, 15°
10888857213371Expandable ALIF, Size 24x30x16 mm, 10°
10888857213364Expandable ALIF Size 30x40x15 mm, 5°
10888857213357Expandable ALIF Size 30x40x15 mm, 10°

Trademark Results [SAHARA]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SAHARA
SAHARA
98349141 not registered Live/Pending
KARABETIAN IMPORT & DISTRIBUTION, INC.
2024-01-09
SAHARA
SAHARA
98188474 not registered Live/Pending
Sahara Group LLC
2023-09-20
SAHARA
SAHARA
98078534 not registered Live/Pending
ADM Flooring Inc
2023-07-10
SAHARA
SAHARA
97864592 not registered Live/Pending
CL Corporation
2023-03-30
SAHARA
SAHARA
97779323 not registered Live/Pending
Lincoln Global, Inc.
2023-02-03
SAHARA
SAHARA
97762925 not registered Live/Pending
1000212825 ONTARIO INC.
2023-01-20
SAHARA
SAHARA
97452440 not registered Live/Pending
Enercorp Engineered Solutions, Inc.
2022-06-10
SAHARA
SAHARA
97400506 not registered Live/Pending
GrabNGo Brands, Inc.
2022-05-09
SAHARA
SAHARA
90444743 not registered Live/Pending
KING EL DANIEL
2021-01-01
SAHARA
SAHARA
88800700 not registered Live/Pending
BASF Corporation
2020-02-18
SAHARA
SAHARA
88704537 not registered Live/Pending
SAHARA DISTRIBUTION LLC
2019-11-24
SAHARA
SAHARA
88621536 not registered Live/Pending
AvenEx Coating Technologies, Inc.
2019-09-18
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