DENALI® MI Spinal System 1001-E5550-SG

GUDID 10888857002029

Contoured Rod, Bulleted Hex, Size Ø5.5x50 mm, Ti

K2M, INC.

Bone-screw internal spinal fixation system, sterile
Primary Device ID10888857002029
NIH Device Record Keydee7229d-edd2-4742-8563-131da145e589
Commercial Distribution StatusIn Commercial Distribution
Brand NameDENALI® MI Spinal System
Version Model Number1001-E5550-SG
Catalog Number1001-E5550-SG
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 Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
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
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
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

Length50 Millimeter
Outer Diameter5.5 Millimeter
Length50 Millimeter
Outer Diameter5.5 Millimeter
Length50 Millimeter
Outer Diameter5.5 Millimeter
Length50 Millimeter
Outer Diameter5.5 Millimeter
Length50 Millimeter
Outer Diameter5.5 Millimeter
Length50 Millimeter
Outer Diameter5.5 Millimeter
Length50 Millimeter
Outer Diameter5.5 Millimeter
Length50 Millimeter
Outer Diameter5.5 Millimeter
Length50 Millimeter
Outer Diameter5.5 Millimeter
Length50 Millimeter
Outer Diameter5.5 Millimeter
Length50 Millimeter
Outer Diameter5.5 Millimeter
Length50 Millimeter
Outer Diameter5.5 Millimeter
Length50 Millimeter
Outer Diameter5.5 Millimeter
Length50 Millimeter
Outer Diameter5.5 Millimeter
Length50 Millimeter
Outer Diameter5.5 Millimeter
Length50 Millimeter
Outer Diameter5.5 Millimeter
Length50 Millimeter
Outer Diameter5.5 Millimeter
Length50 Millimeter
Outer Diameter5.5 Millimeter
Length50 Millimeter
Outer Diameter5.5 Millimeter
Length50 Millimeter
Outer Diameter5.5 Millimeter
Length50 Millimeter
Outer Diameter5.5 Millimeter
Length50 Millimeter
Outer Diameter5.5 Millimeter
Length50 Millimeter
Outer Diameter5.5 Millimeter
Length50 Millimeter
Outer Diameter5.5 Millimeter
Length50 Millimeter
Outer Diameter5.5 Millimeter
Length50 Millimeter
Outer Diameter5.5 Millimeter
Length50 Millimeter
Outer Diameter5.5 Millimeter
Length50 Millimeter
Outer Diameter5.5 Millimeter
Length50 Millimeter
Outer Diameter5.5 Millimeter
Length50 Millimeter
Outer Diameter5.5 Millimeter
Length50 Millimeter
Outer Diameter5.5 Millimeter
Length50 Millimeter
Outer Diameter5.5 Millimeter
Length50 Millimeter
Outer Diameter5.5 Millimeter
Length50 Millimeter
Outer Diameter5.5 Millimeter
Length50 Millimeter
Outer Diameter5.5 Millimeter
Length50 Millimeter
Outer Diameter5.5 Millimeter
Length50 Millimeter
Outer Diameter5.5 Millimeter
Length50 Millimeter
Outer Diameter5.5 Millimeter
Length50 Millimeter
Outer Diameter5.5 Millimeter
Length50 Millimeter
Outer Diameter5.5 Millimeter
Length50 Millimeter
Outer Diameter5.5 Millimeter
Length50 Millimeter
Outer Diameter5.5 Millimeter
Length50 Millimeter
Outer Diameter5.5 Millimeter
Length50 Millimeter
Outer Diameter5.5 Millimeter
Length50 Millimeter
Outer Diameter5.5 Millimeter
Length50 Millimeter
Outer Diameter5.5 Millimeter
Length50 Millimeter
Outer Diameter5.5 Millimeter
Length50 Millimeter
Outer Diameter5.5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS110888857002029 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MNIORTHOSIS, SPINAL PEDICLE FIXATION

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-11-14

On-Brand Devices [DENALI® MI Spinal System]

10888857421004Contoured Rod, Bulleted Hex, Size Ø5.5x120 mm, Ti
10888857420991Contoured Rod, Bulleted Hex, Size Ø5.5x115 mm, Ti
10888857419810Straight Rod, Bulleted Hex, Size Ø5.5x500 mm, Ti
10888857418684Straight Rod, Bulleted Hex, Size Ø5.5x275 mm, Ti
10888857418677Straight Rod, Bulleted Hex, Size Ø5.5x225 mm, Ti
10888857418660Straight Rod, Bulleted Hex, Size Ø5.5x175 mm, Ti
10888857418653Straight Rod, Bulleted Hex, Size Ø5.5x300 mm, Ti
10888857418646Straight Rod, Bulleted Hex, Size Ø5.5x290 mm, Ti
10888857418639Straight Rod, Bulleted Hex, Size Ø5.5x280 mm, Ti
10888857418622Straight Rod, Bulleted Hex, Size Ø5.5x270 mm, Ti
10888857418615Straight Rod, Bulleted Hex, Size Ø5.5x260 mm, Ti
10888857418608Straight Rod, Bulleted Hex, Size Ø5.5x250 mm, Ti
10888857418592Straight Rod, Bulleted Hex, Size Ø5.5x240 mm, Ti
10888857418585Straight Rod, Bulleted Hex, Size Ø5.5x230 mm, Ti
10888857418578Straight Rod, Bulleted Hex, Size Ø5.5x220 mm, Ti
10888857418561Straight Rod, Bulleted Hex, Size Ø5.5x210 mm, Ti
10888857418554Straight Rod, Bulleted Hex, Size Ø5.5x190 mm, Ti
10888857418547Straight Rod, Bulleted Hex, Size Ø5.5x180 mm, Ti
10888857418530Straight Rod, Bulleted Hex, Size Ø5.5x170 mm, Ti
10888857418523Straight Rod, Bulleted Hex, Size Ø5.5x160 mm, Ti
10888857418516Straight Rod, Bulleted Hex, Size Ø5.5x200 mm, Ti
10888857418141Straight Rod, Bulleted Hex, Size Ø5.5x140 mm, Ti
10888857418134Straight Rod, Bulleted Hex, Size Ø5.5x130 mm, Ti
10888857418127Straight Rod, Bulleted Hex, Size Ø5.5x150 mm, Ti
10888857417861Contoured Rod, Bulleted Hex, Size Ø5.5x150 mm, Ti
10888857417847Contoured Rod, Bulleted Hex, Size Ø5.5x140 mm, Ti
10888857417823Contoured Rod, Bulleted Hex, Size Ø5.5x130 mm, Ti
10888857183292Polyaxial Screw, Cannulated, Size Ø4.5x35 mm
10888857183285Polyaxial Screw, Cannulated, Size Ø4.5x30 mm
10888857183278Polyaxial Screw, Cannulated, Size Ø4.5x25 mm
10888857148680Monoaxial Screw, Cannulated, Size Ø8.5x95 mm
10888857148673Monoaxial Screw, Cannulated, Size Ø8.5x90 mm
10888857148666Monoaxial Screw, Cannulated, Size Ø8.5x85 mm
10888857148659Monoaxial Screw, Cannulated, Size Ø8.5x80 mm
10888857148642Monoaxial Screw, Cannulated, Size Ø8.5x75 mm
10888857148635Monoaxial Screw, Cannulated, Size Ø8.5x70 mm
10888857148628Monoaxial Screw, Cannulated, Size Ø8.5x65 mm
10888857148611Monoaxial Screw, Cannulated, Size Ø8.5x60 mm
10888857148604Monoaxial Screw, Cannulated, Size Ø8.5x55 mm
10888857148598Monoaxial Screw, Cannulated, Size Ø8.5x50 mm
10888857148581Monoaxial Screw, Cannulated, Size Ø8.5x45 mm
10888857148574Monoaxial Screw, Cannulated, Size Ø8.5x40 mm
10888857148567Monoaxial Screw, Cannulated, Size Ø8.5x35 mm
10888857148550Monoaxial Screw, Cannulated, Size Ø8.5x30 mm
10888857148543Monoaxial Screw, Cannulated, Size Ø8.5x25 mm
10888857148536Monoaxial Screw, Cannulated, Size Ø8.5x110 mm
10888857148529Monoaxial Screw, Cannulated, Size Ø8.5x105 mm
10888857148512Monoaxial Screw, Cannulated, Size Ø8.5x100 mm
10888857148505Monoaxial Screw, Cannulated, Size Ø7.5x95 mm
10888857148499Monoaxial Screw, Cannulated, Size Ø7.5x90 mm

Trademark Results [DENALI]

Mark Image

Registration | Serial
Company
Trademark
Application Date
DENALI
DENALI
98685102 not registered Live/Pending
DENALI BRANDS, LLC
2024-08-06
DENALI
DENALI
98685100 not registered Live/Pending
DENALI BRANDS, LLC
2024-08-06
DENALI
DENALI
98642977 not registered Live/Pending
Holloway, Kerith
2024-07-11
DENALI
DENALI
98619126 not registered Live/Pending
GP IMPORTS COMERCIO DE PECAS E ACESSORIOS PARA VEICULOS LTDA
2024-06-26
DENALI
DENALI
98408434 not registered Live/Pending
Diamond D Outdoors, LLC
2024-02-16
DENALI
DENALI
98336056 not registered Live/Pending
Perks and Re-creation Disc Golf LLC
2023-12-29
DENALI
DENALI
97720727 not registered Live/Pending
Valmont Industries, Inc.
2022-12-16
DENALI
DENALI
97646291 not registered Live/Pending
True Temper Sports, Inc.
2022-10-25
DENALI
DENALI
97522669 not registered Live/Pending
S. Rays, Inc.
2022-07-27
DENALI
DENALI
97463534 not registered Live/Pending
Denali Water Solutions LLC
2022-06-17
DENALI
DENALI
97463531 not registered Live/Pending
Denali Water Solutions LLC
2022-06-17
DENALI
DENALI
97463528 not registered Live/Pending
Denali Water Solutions LLC
2022-06-17

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