Ni-Lock® Anterior Cervical Plate System 15-N420

GUDID 10840642103762

Screw Fixed Self-Tapping 4.5mm x 20mm

Spine Wave, Inc.

Spinal bone screw, non-bioabsorbable
Primary Device ID10840642103762
NIH Device Record Key922f9f6e-3805-4231-ba28-6bfc3f0ae4f8
Commercial Distribution StatusIn Commercial Distribution
Brand NameNi-Lock® Anterior Cervical Plate System
Version Model Number15-N420
Catalog Number15-N420
Company DUNS067789763
Company NameSpine Wave, 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

Phone203-944-9494
EmailGUDID@spinewave.com
Phone203-944-9494
EmailGUDID@spinewave.com
Phone203-944-9494
EmailGUDID@spinewave.com
Phone203-944-9494
EmailGUDID@spinewave.com
Phone203-944-9494
EmailGUDID@spinewave.com
Phone203-944-9494
EmailGUDID@spinewave.com
Phone203-944-9494
EmailGUDID@spinewave.com
Phone203-944-9494
EmailGUDID@spinewave.com
Phone203-944-9494
EmailGUDID@spinewave.com
Phone203-944-9494
EmailGUDID@spinewave.com
Phone203-944-9494
EmailGUDID@spinewave.com
Phone203-944-9494
EmailGUDID@spinewave.com
Phone203-944-9494
EmailGUDID@spinewave.com
Phone203-944-9494
EmailGUDID@spinewave.com
Phone203-944-9494
EmailGUDID@spinewave.com
Phone203-944-9494
EmailGUDID@spinewave.com
Phone203-944-9494
EmailGUDID@spinewave.com
Phone203-944-9494
EmailGUDID@spinewave.com
Phone203-944-9494
EmailGUDID@spinewave.com
Phone203-944-9494
EmailGUDID@spinewave.com
Phone203-944-9494
EmailGUDID@spinewave.com
Phone203-944-9494
EmailGUDID@spinewave.com
Phone203-944-9494
EmailGUDID@spinewave.com
Phone203-944-9494
EmailGUDID@spinewave.com
Phone203-944-9494
EmailGUDID@spinewave.com
Phone203-944-9494
EmailGUDID@spinewave.com

Device Dimensions

Length20 Millimeter
Outer Diameter4.5 Millimeter
Length20 Millimeter
Outer Diameter4.5 Millimeter
Length20 Millimeter
Outer Diameter4.5 Millimeter
Length20 Millimeter
Outer Diameter4.5 Millimeter
Length20 Millimeter
Outer Diameter4.5 Millimeter
Length20 Millimeter
Outer Diameter4.5 Millimeter
Length20 Millimeter
Outer Diameter4.5 Millimeter
Length20 Millimeter
Outer Diameter4.5 Millimeter
Length20 Millimeter
Outer Diameter4.5 Millimeter
Length20 Millimeter
Outer Diameter4.5 Millimeter
Length20 Millimeter
Outer Diameter4.5 Millimeter
Length20 Millimeter
Outer Diameter4.5 Millimeter
Length20 Millimeter
Outer Diameter4.5 Millimeter
Length20 Millimeter
Outer Diameter4.5 Millimeter
Length20 Millimeter
Outer Diameter4.5 Millimeter
Length20 Millimeter
Outer Diameter4.5 Millimeter
Length20 Millimeter
Outer Diameter4.5 Millimeter
Length20 Millimeter
Outer Diameter4.5 Millimeter
Length20 Millimeter
Outer Diameter4.5 Millimeter
Length20 Millimeter
Outer Diameter4.5 Millimeter
Length20 Millimeter
Outer Diameter4.5 Millimeter
Length20 Millimeter
Outer Diameter4.5 Millimeter
Length20 Millimeter
Outer Diameter4.5 Millimeter
Length20 Millimeter
Outer Diameter4.5 Millimeter
Length20 Millimeter
Outer Diameter4.5 Millimeter
Length20 Millimeter
Outer Diameter4.5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS110840642103762 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAppliance, Fixation, Spinal Intervertebral Body

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10840642103762]

Moist Heat or Steam Sterilization


[10840642103762]

Moist Heat or Steam Sterilization


[10840642103762]

Moist Heat or Steam Sterilization


[10840642103762]

Moist Heat or Steam Sterilization


[10840642103762]

Moist Heat or Steam Sterilization


[10840642103762]

Moist Heat or Steam Sterilization


[10840642103762]

Moist Heat or Steam Sterilization


[10840642103762]

Moist Heat or Steam Sterilization


[10840642103762]

Moist Heat or Steam Sterilization


[10840642103762]

Moist Heat or Steam Sterilization


[10840642103762]

Moist Heat or Steam Sterilization


[10840642103762]

Moist Heat or Steam Sterilization


[10840642103762]

Moist Heat or Steam Sterilization


[10840642103762]

Moist Heat or Steam Sterilization


[10840642103762]

Moist Heat or Steam Sterilization


[10840642103762]

Moist Heat or Steam Sterilization


[10840642103762]

Moist Heat or Steam Sterilization


[10840642103762]

Moist Heat or Steam Sterilization


[10840642103762]

Moist Heat or Steam Sterilization


[10840642103762]

Moist Heat or Steam Sterilization


[10840642103762]

Moist Heat or Steam Sterilization


[10840642103762]

Moist Heat or Steam Sterilization


[10840642103762]

Moist Heat or Steam Sterilization


[10840642103762]

Moist Heat or Steam Sterilization


[10840642103762]

Moist Heat or Steam Sterilization


[10840642103762]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2024-07-12
Device Publish Date2015-10-24

On-Brand Devices [Ni-Lock® Anterior Cervical Plate System]

10840642103076Plate 50mm 3 Level
10840642103069Plate 48mm 3 Level
10840642103052Plate 44mm 3 Level
10840642103045Plate 40mm 3 Level
10840642103038Plate 44mm 2 Level
10840642103021Plate 40mm 2 Level
10840642103014Plate 36mm 2 Level
10840642103007Plate 34mm 2 Level
10840642102994Plate 32mm 2 Level
10840642102987Plate 30mm 2 Level
10840642103250Plate 84mm 4 Level
10840642103243Plate 80mm 4 Level
10840642103236Plate 76mm 4 Level
10840642103229Plate 72mm 4 Level
10840642103212Plate 68mm 4 Level
10840642103205Plate 64mm 4 Level
10840642103199Plate 60mm 4 Level
10840642103106Plate 62mm 3 Level
10840642103090Plate 58mm 3 Level
10840642103083Plate 54mm 3 Level
10840642102970Plate 28mm 2 Level
10840642102963Plate 26mm 2 Level
10840642102956Plate 24mm 2 Level
10840642102949Plate 22mm 2 Level
10840642102932Plate 20mm 2 Level
10840642102925Plate 26mm 1 Level
10840642102918Plate 24mm 1 Level
10840642102901Plate 22mm 1 Level
10840642102895Plate 20mm 1 Level
10840642102888Plate 18mm 1 Level
10840642102871Plate 16mm 1 Level
10840642103885Screw Fixed Self-Drilling 4.0mm x 20mm
10840642103878Screw Fixed Self-Drilling 4.0mm x 18mm
10840642103861Screw Fixed Self-Drilling 4.0mm x 16mm
10840642103854Screw Fixed Self-Drilling 4.0mm x 14mm
10840642103847Screw Fixed Self-Drilling 4.0mm x 12mm
10840642103830Screw Fixed Self-Drilling 4.0mm x 10mm
10840642103823Screw Variable Self-Drilling 4.0mm x 20mm
10840642103816Screw Variable Self-Drilling 4.0mm x 18mm
10840642103809Screw Variable Self-Drilling 4.0mm x 16mm
10840642103793Screw Variable Self-Drilling 4.0mm x 14mm
10840642103786Screw Variable Self-Drilling 4.0mm x 12mm
10840642103779Screw Variable Self-Drilling 4.0mm x 10mm
10840642103762Screw Fixed Self-Tapping 4.5mm x 20mm
10840642103755Screw Fixed Self-Tapping 4.5mm x 18mm
10840642103748Screw Fixed Self-Tapping 4.5mm x 16mm
10840642103731Screw Fixed Self-Tapping 4.5mm x 14mm
10840642103724Screw Fixed Self-Tapping 4.5mm x 12mm
10840642103717Screw Fixed Self-Tapping 4.5mm x 10mm
10840642103700Screw Variable Self-Tapping 4.5mm x 20mm

Trademark Results [Ni-Lock]

Mark Image

Registration | Serial
Company
Trademark
Application Date
NI-LOCK
NI-LOCK
85513578 4239245 Live/Registered
Spine Wave, Inc.
2012-01-11

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