NexGen Anterior Cervical Plate System 65-IN-0090

GUDID 00840019938754

Double Barrel DTS Guide - 0°

PRECISION SPINE, INC.

Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable
Primary Device ID00840019938754
NIH Device Record Keyc51a52c0-00bc-4aeb-ad95-c14d01f601b9
Commercial Distribution StatusIn Commercial Distribution
Brand NameNexGen Anterior Cervical Plate System
Version Model Number65-IN-0090
Catalog Number65-IN-0090
Company DUNS079398589
Company NamePRECISION SPINE, INC.
Device Count1
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100840019938754 [Primary]
GS100840019938754 [Primary]
GS100840019938754 [Primary]
GS100840019938754 [Primary]
GS100840019938754 [Primary]
GS100840019938754 [Primary]
GS100840019938754 [Primary]
GS100840019938754 [Primary]
GS100840019938754 [Primary]
GS100840019938754 [Primary]
GS100840019938754 [Primary]
GS100840019938754 [Primary]
GS100840019938754 [Primary]
GS100840019938754 [Primary]
GS100840019938754 [Primary]

FDA Product Code

FZXGuide, Surgical, Instrument
FZXGuide, Surgical, Instrument
FZXGuide, Surgical, Instrument
FZXGuide, Surgical, Instrument
FZXGuide, Surgical, Instrument
FZXGuide, Surgical, Instrument
FZXGuide, Surgical, Instrument
FZXGuide, Surgical, Instrument
FZXGuide, Surgical, Instrument
FZXGuide, Surgical, Instrument
FZXGuide, Surgical, Instrument
FZXGuide, Surgical, Instrument
FZXGuide, Surgical, Instrument
FZXGuide, Surgical, Instrument
FZXGuide, Surgical, Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840019938754]

Moist Heat or Steam Sterilization


[00840019938754]

Moist Heat or Steam Sterilization


[00840019938754]

Moist Heat or Steam Sterilization


[00840019938754]

Moist Heat or Steam Sterilization


[00840019938754]

Moist Heat or Steam Sterilization


[00840019938754]

Moist Heat or Steam Sterilization


[00840019938754]

Moist Heat or Steam Sterilization


[00840019938754]

Moist Heat or Steam Sterilization


[00840019938754]

Moist Heat or Steam Sterilization


[00840019938754]

Moist Heat or Steam Sterilization


[00840019938754]

Moist Heat or Steam Sterilization


[00840019938754]

Moist Heat or Steam Sterilization


[00840019938754]

Moist Heat or Steam Sterilization


[00840019938754]

Moist Heat or Steam Sterilization


[00840019938754]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-06-17
Device Publish Date2020-06-09

On-Brand Devices [NexGen Anterior Cervical Plate System]

00840019936071Anterior Cervical Plate 4 Level - 64mm
00840019936064Anterior Cervical Plate 4 Level - 60mm
00840019936057Anterior Cervical Plate 3 Level - 67mm
00840019936040Anterior Cervical Plate 3 Level - 64mm
00840019936033Anterior Cervical Plate 3 Level - 61mm
00840019936026Anterior Cervical Plate 3 Level - 58mm
00840019933360Anterior Cervical Plate 3 Level - 55mm
00840019933353Anterior Cervical Plate 3 Level - 52mm
00840019933346Anterior Cervical Plate 3 Level - 49mm
00840019933339Anterior Cervical Plate 3 Level - 46mm
00840019933322Anterior Cervical Plate 3 Level - 43mm
00840019933315Anterior Cervical Plate 2 Level - 46mm
00840019933308Anterior Cervical Plate 2 Level - 44mm
00840019933292Anterior Cervical Plate 2 Level - 42mm
00840019933285Anterior Cervical Plate 2 Level - 40mm
00840019933278Anterior Cervical Plate 2 Level - 38mm
00840019933261Anterior Cervical Plate 2 Level - 36mm
00840019933254Anterior Cervical Plate 2 Level - 34mm
00840019933247Anterior Cervical Plate 2 Level - 32mm
00840019933230Anterior Cervical Plate 2 Level - 30mm
00840019933223Anterior Cervical Plate 2 Level - 28mm
00840019933216Anterior Cervical Plate 2 Level - 26mm
00840019933209Anterior Cervical Plate 2 Level - 24mm
00840019933193Anterior Cervical Plate 1 Level - 26mm
00840019933179Anterior Cervical Plate 1 Level - 22mm
00840019933162Anterior Cervical Plate 1 Level - 20mm
00840019933155Anterior Cervical Plate 1 Level - 18mm
00840019933148Anterior Cervical Plate 1 Level - 16mm
00840019933131Anterior Cervical Plate 1 Level - 14mm
00840019933124Anterior Cervical Plate 1 Level - 12mm
00840019933117Anterior Cervical Plate 1 Level - 10mm
00840019933100Self-Tapping Fixed Screw - 4.5mm x 18mm
00840019933094Self-Tapping Fixed Screw - 4.5mm x 16mm
00840019933087Self-Tapping Fixed Screw - 4.5mm x 14mm
00840019933070Self-Tapping Fixed Screw - 4.5mm x 12mm
00840019933063Self-Tapping Fixed Screw - 4.5mm x 10mm
00840019933056Self-Tapping Variable Screw - 4.5mm x 18mm
00840019933049Self-Tapping Variable Screw - 4.5mm x 16mm
00840019933032Self-Tapping Variable Screw - 4.5mm x 14mm
00840019933025Self-Tapping Variable Screw - 4.5mm x 12mm
00840019933018Self-Tapping Variable Screw - 4.5mm x 10mm
00840019933001Self-Drilling Fixed Screw - 4.5mm x 18mm
00840019932998Self-Drilling Fixed Screw - 4.5mm x 16mm
00840019932981Self-Drilling Fixed Screw - 4.5mm x 14mm
00840019932974Self-Drilling Fixed Screw - 4.5mm x 12mm
00840019932967Self-Drilling Fixed Screw - 4.5mm x 10mm
00840019932950Self-Drilling Variable Screw - 4.5mm x 18mm
00840019932943Self-Drilling Variable Screw - 4.5mm x 16mm
00840019932936Self-Drilling Variable Screw - 4.5mm x 14mm
00840019932929Self-Drilling Variable Screw - 4.5mm x 12mm

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