Modular Fixation System NC055-040-4

GUDID 00190837076603

Bone Screw, 5.5mm x 40mm, Noncannulated

Life Spine, Inc.

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00190837076603
NIH Device Record Key64f72b6f-2165-40ca-bf09-184d5a2b7335
Commercial Distribution StatusIn Commercial Distribution
Brand NameModular Fixation System
Version Model NumberNC055-040-4
Catalog NumberNC055-040-4
Company DUNS183641617
Company NameLife Spine, 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

Device Identifiers

Device Issuing AgencyDevice ID
GS100190837076603 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKBThoracolumbosacral pedicle screw system

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00190837076603]

Moist Heat or Steam Sterilization


[00190837076603]

Moist Heat or Steam Sterilization


[00190837076603]

Moist Heat or Steam Sterilization


[00190837076603]

Moist Heat or Steam Sterilization


[00190837076603]

Moist Heat or Steam Sterilization


[00190837076603]

Moist Heat or Steam Sterilization


[00190837076603]

Moist Heat or Steam Sterilization


[00190837076603]

Moist Heat or Steam Sterilization


[00190837076603]

Moist Heat or Steam Sterilization


[00190837076603]

Moist Heat or Steam Sterilization


[00190837076603]

Moist Heat or Steam Sterilization


[00190837076603]

Moist Heat or Steam Sterilization


[00190837076603]

Moist Heat or Steam Sterilization


[00190837076603]

Moist Heat or Steam Sterilization


[00190837076603]

Moist Heat or Steam Sterilization


[00190837076603]

Moist Heat or Steam Sterilization


[00190837076603]

Moist Heat or Steam Sterilization


[00190837076603]

Moist Heat or Steam Sterilization


[00190837076603]

Moist Heat or Steam Sterilization


[00190837076603]

Moist Heat or Steam Sterilization


[00190837076603]

Moist Heat or Steam Sterilization


[00190837076603]

Moist Heat or Steam Sterilization


[00190837076603]

Moist Heat or Steam Sterilization


[00190837076603]

Moist Heat or Steam Sterilization


[00190837076603]

Moist Heat or Steam Sterilization


[00190837076603]

Moist Heat or Steam Sterilization


[00190837076603]

Moist Heat or Steam Sterilization


[00190837076603]

Moist Heat or Steam Sterilization


[00190837076603]

Moist Heat or Steam Sterilization


[00190837076603]

Moist Heat or Steam Sterilization


[00190837076603]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-11-14
Device Publish Date2019-11-06

On-Brand Devices [Modular Fixation System]

00190837076771Bone Screw, 7.5mm x 55mm, Noncannulated
00190837076764Bone Screw, 7.5mm x 50mm, Noncannulated
00190837076757Bone Screw, 7.5mm x 45mm, Noncannulated
00190837076740Bone Screw, 7.5mm x 40mm, Noncannulated
00190837076733Bone Screw, 7.5mm x 35mm, Noncannulated
00190837076726Bone Screw, 7.5mm x 30mm, Noncannulated
00190837076719Bone Screw, 7.5mm x 25mm, Noncannulated
00190837076702Bone Screw, 6.5mm x 55mm, Noncannulated
00190837076696Bone Screw, 6.5mm x 50mm, Noncannulated
00190837076689Bone Screw, 6.5mm x 45mm, Noncannulated
00190837076672Bone Screw, 6.5mm x 40mm, Noncannulated
00190837076665Bone Screw, 6.5mm x 35mm, Noncannulated
00190837076658Bone Screw, 6.5mm x 30mm, Noncannulated
00190837076641Bone Screw, 6.5mm x 25mm, Noncannulated
00190837076634Bone Screw, 5.5mm x 55mm, Noncannulated
00190837076627Bone Screw, 5.5mm x 50mm, Noncannulated
00190837076610Bone Screw, 5.5mm x 45mm, Noncannulated
00190837076603Bone Screw, 5.5mm x 40mm, Noncannulated
00190837076597Bone Screw, 5.5mm x 35mm, Noncannulated
00190837076580Bone Screw, 5.5mm x 30mm, Noncannulated
00190837076573Bone Screw, 5.5mm x 25mm, Noncannulated
00190837076566Bone Screw, 5.0mm x 50mm, Noncannulated
00190837076559Bone Screw, 5.0mm x 45mm, Noncannulated
00190837076542Bone Screw, 5.0mm x 40mm, Noncannulated
00190837076535Bone Screw, 5.0mm x 35mm, Noncannulated
00190837076528Bone Screw, 5.0mm x 30mm, Noncannulated
00190837076511Bone Screw, 5.0mm x 25mm, Noncannulated
00190837076504Bone Screw, 4.5mm x 55mm, Noncannulated
00190837076498Bone Screw, 4.5mm x 50mm, Noncannulated
00190837076481Bone Screw, 4.5mm x 45mm, Noncannulated
00190837076474Bone Screw, 4.5mm x 40mm, Noncannulated
00190837076467Bone Screw, 4.5mm x 35mm, Noncannulated
00190837076450Bone Screw, 4.5mm x 30mm, Noncannulated
00190837076443Bone Screw, 4.5mm x 25mm, Noncannulated
001908370764291/4 Square Distractor Driver
00190837076405Modular Tip - Lamina Spreader - Left
00190837076399Modular Tip - Shank Distraction - Right
00190837076351360 Cortical Reamer
001908370763134.75mm Rod Caddy
00190837076306Centerline Drill for 7.5mm Screw
00190837086077Threaded Tulip Inserter with Verifier
00190837076436Modular Tulip Head, 4.0mm-7.5mm
00190837076412Modular Tip - Lamina Spreader - Right
00190837076382Modular Tip - Shank Distraction - Left
00190837076375Screw Distractor
00190837076368Bottom Cutting Cortical Reamer
00190837076344Threaded Tulip Inserter
00190837076337Forceps-Style Tulip Inserter
00190837076320Modular Screwdriver
00190837076290Centerline Depth Stop, Adjustable Drill Guide

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