DENALI® Spinal System 101-A55400

GUDID 10888857011526

Straight Deformity Rod, Hex, Size Ø5.5x400 mm, Ti

K2M, INC.

Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile
Primary Device ID10888857011526
NIH Device Record Key9f48a564-1d9a-4ce4-b258-22d549c095c9
Commercial Distribution StatusIn Commercial Distribution
Brand NameDENALI® Spinal System
Version Model Number101-A55400
Catalog Number101-A55400
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
Emailmzellers@k2m.com
Phone+1(703)777-3155
Emailmzellers@k2m.com
Phone+1(703)777-3155
Emailmzellers@k2m.com
Phone+1(703)777-3155
Emailmzellers@k2m.com
Phone+1(703)777-3155
Emailmzellers@k2m.com
Phone+1(703)777-3155
Emailmzellers@k2m.com
Phone+1(703)777-3155
Emailmzellers@k2m.com
Phone+1(703)777-3155
Emailmzellers@k2m.com
Phone+1(703)777-3155
Emailmzellers@k2m.com
Phone+1(703)777-3155
Emailmzellers@k2m.com
Phone+1(703)777-3155
Emailmzellers@k2m.com
Phone+1(703)777-3155
Emailmzellers@k2m.com
Phone+1(703)777-3155
Emailmzellers@k2m.com
Phone+1(703)777-3155
Emailmzellers@k2m.com
Phone+1(703)777-3155
Emailmzellers@k2m.com
Phone+1(703)777-3155
Emailmzellers@k2m.com
Phone+1(703)777-3155
Emailmzellers@k2m.com
Phone+1(703)777-3155
Emailmzellers@k2m.com
Phone+1(703)777-3155
Emailmzellers@k2m.com

Device Dimensions

Length400 Millimeter
Outer Diameter5.5 Millimeter
Length400 Millimeter
Outer Diameter5.5 Millimeter
Length400 Millimeter
Outer Diameter5.5 Millimeter
Length400 Millimeter
Outer Diameter5.5 Millimeter
Length400 Millimeter
Outer Diameter5.5 Millimeter
Length400 Millimeter
Outer Diameter5.5 Millimeter
Length400 Millimeter
Outer Diameter5.5 Millimeter
Length400 Millimeter
Outer Diameter5.5 Millimeter
Length400 Millimeter
Outer Diameter5.5 Millimeter
Length400 Millimeter
Outer Diameter5.5 Millimeter
Length400 Millimeter
Outer Diameter5.5 Millimeter
Length400 Millimeter
Outer Diameter5.5 Millimeter
Length400 Millimeter
Outer Diameter5.5 Millimeter
Length400 Millimeter
Outer Diameter5.5 Millimeter
Length400 Millimeter
Outer Diameter5.5 Millimeter
Length400 Millimeter
Outer Diameter5.5 Millimeter
Length400 Millimeter
Outer Diameter5.5 Millimeter
Length400 Millimeter
Outer Diameter5.5 Millimeter
Length400 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS110888857011526 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MNIOrthosis, spinal pedicle fixation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10888857011526]

Moist Heat or Steam Sterilization


[10888857011526]

Moist Heat or Steam Sterilization


[10888857011526]

Moist Heat or Steam Sterilization


[10888857011526]

Moist Heat or Steam Sterilization


[10888857011526]

Moist Heat or Steam Sterilization


[10888857011526]

Moist Heat or Steam Sterilization


[10888857011526]

Moist Heat or Steam Sterilization


[10888857011526]

Moist Heat or Steam Sterilization


[10888857011526]

Moist Heat or Steam Sterilization


[10888857011526]

Moist Heat or Steam Sterilization


[10888857011526]

Moist Heat or Steam Sterilization


[10888857011526]

Moist Heat or Steam Sterilization


[10888857011526]

Moist Heat or Steam Sterilization


[10888857011526]

Moist Heat or Steam Sterilization


[10888857011526]

Moist Heat or Steam Sterilization


[10888857011526]

Moist Heat or Steam Sterilization


[10888857011526]

Moist Heat or Steam Sterilization


[10888857011526]

Moist Heat or Steam Sterilization


[10888857011526]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-11-19
Device Publish Date2019-11-11

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

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