NILE™ Proximal Fixation System 5401-70040A

GUDID 10888857291256

Semi-Adj Transverse Connector Dual Slot, Size 40 mm

K2M, INC.

Cannulated surgical drill bit, single-use, sterile
Primary Device ID10888857291256
NIH Device Record Key99033933-f508-479f-a040-ef096d668947
Commercial Distribution StatusIn Commercial Distribution
Brand NameNILE™ Proximal Fixation System
Version Model Number5401-70040A
Catalog Number5401-70040A
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(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

Outer Diameter6 Millimeter
Length40 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter6 Millimeter
Length40 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter6 Millimeter
Length40 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter6 Millimeter
Length40 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter6 Millimeter
Length40 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter6 Millimeter
Length40 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter6 Millimeter
Length40 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter6 Millimeter
Length40 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter6 Millimeter
Length40 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter6 Millimeter
Length40 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter6 Millimeter
Length40 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter6 Millimeter
Length40 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter6 Millimeter
Length40 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter6 Millimeter
Length40 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter6 Millimeter
Length40 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter6 Millimeter
Length40 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter6 Millimeter
Length40 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter6 Millimeter
Length40 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter6 Millimeter
Length40 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter6 Millimeter
Length40 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter6 Millimeter
Length40 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter6 Millimeter
Length40 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter6 Millimeter
Length40 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter6 Millimeter
Length40 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter6 Millimeter
Length40 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter6 Millimeter
Length40 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter6 Millimeter
Length40 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter6 Millimeter
Length40 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter6 Millimeter
Length40 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter6 Millimeter
Length40 Millimeter
Outer Diameter5.5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS110888857291256 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OWIBone fixation cerclage, sublaminar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10888857291256]

Moist Heat or Steam Sterilization

[10888857291256]

Moist Heat or Steam Sterilization

[10888857291256]

Moist Heat or Steam Sterilization

[10888857291256]

Moist Heat or Steam Sterilization

[10888857291256]

Moist Heat or Steam Sterilization

[10888857291256]

Moist Heat or Steam Sterilization

[10888857291256]

Moist Heat or Steam Sterilization

[10888857291256]

Moist Heat or Steam Sterilization

[10888857291256]

Moist Heat or Steam Sterilization

[10888857291256]

Moist Heat or Steam Sterilization

[10888857291256]

Moist Heat or Steam Sterilization

[10888857291256]

Moist Heat or Steam Sterilization

[10888857291256]

Moist Heat or Steam Sterilization

[10888857291256]

Moist Heat or Steam Sterilization

[10888857291256]

Moist Heat or Steam Sterilization

[10888857291256]

Moist Heat or Steam Sterilization

[10888857291256]

Moist Heat or Steam Sterilization

[10888857291256]

Moist Heat or Steam Sterilization

[10888857291256]

Moist Heat or Steam Sterilization

[10888857291256]

Moist Heat or Steam Sterilization

[10888857291256]

Moist Heat or Steam Sterilization

[10888857291256]

Moist Heat or Steam Sterilization

[10888857291256]

Moist Heat or Steam Sterilization

[10888857291256]

Moist Heat or Steam Sterilization

[10888857291256]

Moist Heat or Steam Sterilization

[10888857291256]

Moist Heat or Steam Sterilization

[10888857291256]

Moist Heat or Steam Sterilization

[10888857291256]

Moist Heat or Steam Sterilization

[10888857291256]

Moist Heat or Steam Sterilization

[10888857291256]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2018-11-22
Device Publish Date2017-06-19

On-Brand Devices [NILE™ Proximal Fixation System]

10888857384156Tensioner
10888857306745Anchor Inserter
10888857306738Tensioner
10888857291287Medial Offset Connector
10888857291270Semi-Adj Transverse Connector Single Slot, Size 28 mm
10888857291263Semi-Adj Transverse Connector Dual Slot, Size 34 mm
10888857291256Semi-Adj Transverse Connector Dual Slot, Size 40 mm
10888857291249Semi-Adj Transverse Connector Single Slot, Size 31 mm
10888857291232Semi-Adj Transverse Connector Dual Slot, Size 37 mm
10888857291225Semi-Adj Transverse Connector Dual Slot, Size 43 mm
10888857291195Transverse Connector, Adjustable, Size 45 mm - 48 mm
10888857291188Transverse Connector, Adjustable, Size 50 mm - 58 mm
10888857291171Transverse Connector, Adjustable, Size 47 mm - 52 mm

Trademark Results [NILE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
NILE
NILE
98807227 not registered Live/Pending
Nile Global, Inc.
2024-10-17
NILE
NILE
98202730 not registered Live/Pending
Aphid, Inc.
2023-09-28
NILE
NILE
97646349 not registered Live/Pending
Aphid, Inc.
2022-10-25
NILE
NILE
97251384 not registered Live/Pending
Nile Global, Inc.
2022-02-03
NILE
NILE
97250132 not registered Live/Pending
Nile Global, Inc.
2022-02-02
NILE
NILE
97243819 not registered Live/Pending
Bath Authority LLC
2022-01-28
NILE
NILE
97133060 not registered Live/Pending
Nile AI, Inc.
2021-11-18
NILE
NILE
97118749 not registered Live/Pending
Subramanian, Sriram
2021-11-10
NILE
NILE
90649531 not registered Live/Pending
Walker Defense Research LLC
2021-04-16
NILE
NILE
90467835 not registered Live/Pending
Nile AI, Inc.
2021-01-15
NILE
NILE
90252179 not registered Live/Pending
Aphid, Inc.
2020-10-13
NILE
NILE
88947470 not registered Live/Pending
Aphid, Inc.
2020-06-04
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