DENALI® Spinal System 101-S9002

GUDID 10888857012011

Pedicle Screw Standoff

K2M, INC.

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID10888857012011
NIH Device Record Key54e11015-f85b-4fb0-b5ef-fcd16ce0cfe9
Commercial Distribution StatusIn Commercial Distribution
Brand NameDENALI® Spinal System
Version Model Number101-S9002
Catalog Number101-S9002
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
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

Height2.5 Millimeter
Height2.5 Millimeter
Height2.5 Millimeter
Height2.5 Millimeter
Height2.5 Millimeter
Height2.5 Millimeter
Height2.5 Millimeter
Height2.5 Millimeter
Height2.5 Millimeter
Height2.5 Millimeter
Height2.5 Millimeter
Height2.5 Millimeter
Height2.5 Millimeter
Height2.5 Millimeter
Height2.5 Millimeter
Height2.5 Millimeter
Height2.5 Millimeter
Height2.5 Millimeter
Height2.5 Millimeter
Height2.5 Millimeter
Height2.5 Millimeter
Height2.5 Millimeter
Height2.5 Millimeter
Height2.5 Millimeter
Height2.5 Millimeter
Height2.5 Millimeter
Height2.5 Millimeter
Height2.5 Millimeter
Height2.5 Millimeter
Height2.5 Millimeter
Height2.5 Millimeter
Height2.5 Millimeter
Height2.5 Millimeter
Height2.5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS110888857012011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MNHOrthosis, spondylolisthesis spinal fixation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10888857012011]

Moist Heat or Steam Sterilization

[10888857012011]

Moist Heat or Steam Sterilization

[10888857012011]

Moist Heat or Steam Sterilization

[10888857012011]

Moist Heat or Steam Sterilization

[10888857012011]

Moist Heat or Steam Sterilization

[10888857012011]

Moist Heat or Steam Sterilization

[10888857012011]

Moist Heat or Steam Sterilization

[10888857012011]

Moist Heat or Steam Sterilization

[10888857012011]

Moist Heat or Steam Sterilization

[10888857012011]

Moist Heat or Steam Sterilization

[10888857012011]

Moist Heat or Steam Sterilization

[10888857012011]

Moist Heat or Steam Sterilization

[10888857012011]

Moist Heat or Steam Sterilization

[10888857012011]

Moist Heat or Steam Sterilization

[10888857012011]

Moist Heat or Steam Sterilization

[10888857012011]

Moist Heat or Steam Sterilization

[10888857012011]

Moist Heat or Steam Sterilization

[10888857012011]

Moist Heat or Steam Sterilization

[10888857012011]

Moist Heat or Steam Sterilization

[10888857012011]

Moist Heat or Steam Sterilization

[10888857012011]

Moist Heat or Steam Sterilization

[10888857012011]

Moist Heat or Steam Sterilization

[10888857012011]

Moist Heat or Steam Sterilization

[10888857012011]

Moist Heat or Steam Sterilization

[10888857012011]

Moist Heat or Steam Sterilization

[10888857012011]

Moist Heat or Steam Sterilization

[10888857012011]

Moist Heat or Steam Sterilization

[10888857012011]

Moist Heat or Steam Sterilization

[10888857012011]

Moist Heat or Steam Sterilization

[10888857012011]

Moist Heat or Steam Sterilization

[10888857012011]

Moist Heat or Steam Sterilization

[10888857012011]

Moist Heat or Steam Sterilization

[10888857012011]

Moist Heat or Steam Sterilization

[10888857012011]

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 [DENALI® Spinal System]

10888857421028Straight Deformity Rod, Hex, Size Ø5.5x120 mm, Ti
10888857421011Straight Rod, Size Ø5.5x120 mm Ti
10888857420519Straight Deformity Rod, Dual Hex, Size Ø5.5x600 mm, CoCr
10888857420502Straight Deformity Rod, Hex, Size Ø5.5x600 mm, CP4
10888857420496Straight Deformity Rod, Hex, Size Ø5.5x600 mm, Ti
10888857420069Straight Deformity Rod, Dual Hex, Size Ø5.5x500 mm CoCr
10888857420052Straight Def. Rod, Dual Hex Stop, Size Ø5.5x500 mm, CoCr
10888857420045Straight Deformity Rod, Dual Hex, Size Ø5.5x400 mm, CoCr
10888857420038Straight Def. Rod, Dual Hex Stop, Size Ø5.5x400 mm, CoCr
10888857420021Straight Deformity Rod, Hex, Size Ø5.5x500 mm, CoCr
10888857420014Straight Deformity Rod, Hex, Size Ø5.5x400 mm, CoCr
10888857419971Straight Deformity Rod, Hex, Size Ø5.5x500 mm CP3
10888857419964Straight Deformity Rod, Hex, Size Ø5.5x400 mm, CP3
10888857419957Straight Deformity Rod, Hex, Size Ø5.5x500 mm CP4
10888857419940Straight Deformity Rod, Hex, Size Ø5.5x400 mm, CP4
10888857419933Straight Deformity Rod, Dual Hex, Size Ø5.5x500 mm, Ti
10888857419926Straight Def. Rod, Dual Hex Stop, Size Ø5.5x500 mm, Ti
10888857419919Straight Deformity Rod, Dual Hex, Size Ø5.5x400 mm, Ti
10888857419902Straight Def. Rod, Dual Hex Stop, Size Ø5.5x400 mm, Ti
10888857419896Straight Deformity Rod, Hex, Size Ø5.5x500 mm Ti
10888857419889Straight Deformity Rod, Hex, Size Ø5.5x400 mm, Ti
10888857419872Straight Rod, Size Ø5.5x500 mm, Ti
10888857419865Straight Rod, Size Ø5.5x400 mm, Ti
10888857419629Straight Deformity Rod, Dual Hex, Size Ø5.5x300 mm, CoCr
10888857419612Straight Def. Rod, Dual Hex Stop, Size Ø5.5x300 mm, CoCr
10888857419605Straight Deformity Rod, Dual Hex, Size Ø5.5x200 mm, CoCr
10888857419599Straight Def. Rod, Dual Hex Stop, Size Ø5.5x200 mm, CoCr
10888857419582Straight Deformity Rod, Hex, Size Ø5.5x300 mm, CoCr
10888857419575Straight Deformity Rod, Hex, Size Ø5.5x200 mm, CoCr
10888857419520Straight Deformity Rod, Hex, Size Ø5.5x300 mm, CP3
10888857419513Straight Deformity Rod, Hex, Size Ø5.5x200 mm, CP3
10888857419506Straight Deformity Rod, Hex, Size Ø5.5x300 mm, CP4
10888857419490Straight Deformity Rod, Hex, Size Ø5.5x200 mm, CP4
10888857419483Straight Deformity Rod, Dual Hex, Size Ø5.5x300 mm, Ti
10888857419476Straight Def. Rod, Dual Hex Stop, Size Ø5.5x300 mm, Ti
10888857419469Straight Deformity Rod, Dual Hex, Size Ø5.5x200 mm, Ti
10888857419452Straight Def. Rod, Dual Hex Stop, Size Ø5.5x200 mm, Ti
10888857419445Straight Deformity Rod, Hex, Size Ø5.5x300 mm, Ti
10888857419438Straight Deformity Rod, Hex, Size Ø5.5x200 mm, Ti
10888857419421Straight Rod, Size Ø5.5x300 mm, Ti
10888857419414Straight Rod, Size Ø5.5x200 mm Ti
10888857418493Offset Rod, Size Ø5.5x300 mm, CoCr
10888857418486Offset Rod, Size Ø5.5x300 mm, Ti
10888857417977Contoured Rod, Size Ø5.5x150 mm, CoCr
10888857417960Contoured Rod, Size Ø5.5x125 mm, CoCr
10888857417953Straight Rod, Size Ø5.5x140 mm, Ti
10888857417946Straight Rod, Size Ø5.5x130 mm, Ti
10888857417915Straight Deformity Rod, Dual Hex, Size Ø5.5x150 mm, Ti
10888857417908Straight Deformity Rod, Hex, Size Ø5.5x150 mm, Ti
10888857417892Straight Rod, Size Ø5.5x150 mm Ti

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
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.