Spine System LV01374

GUDID 00880304992726

BIOMET SPINE LLC

General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit
Primary Device ID00880304992726
NIH Device Record Keyfd084280-7462-469c-9ded-ec21162472a4
Commercial Distribution StatusIn Commercial Distribution
Brand NameSpine System
Version Model NumberLV01374
Catalog NumberLV01374
Company DUNS018577570
Company NameBIOMET SPINE LLC
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 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

Customer Support Contacts

Phone+1(800)447-3625
EmailUSBROCustomerService@zimmerbiomet.com
Phone+1(800)447-3625
EmailUSBROCustomerService@zimmerbiomet.com
Phone+1(800)447-3625
EmailUSBROCustomerService@zimmerbiomet.com
Phone+1(800)447-3625
EmailUSBROCustomerService@zimmerbiomet.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100880304992726 [Primary]
GS100880304992726 [Primary]
GS100880304992726 [Primary]
GS100880304992726 [Primary]

FDA Product Code

NKBThoracolumbosacral pedicle screw system
NKBThoracolumbosacral pedicle screw system
NKBThoracolumbosacral pedicle screw system
NKBThoracolumbosacral pedicle screw system

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00880304992726]

Moist Heat or Steam Sterilization


[00880304992726]

Moist Heat or Steam Sterilization


[00880304992726]

Moist Heat or Steam Sterilization


[00880304992726]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-21
Device Publish Date2020-05-13

On-Brand Devices [Spine System]

008803048548198600-9915
008803048548028600-9914
008803048519868600-1400
008803048320468632-3120
008803048320398632-3118
008803048320228632-3116
008803048320158632-3114
008803048320088632-3112
008803048319958632-3110
008803048319888632-3020
008803048319718632-3018
008803048319648632-3016
008803048319578632-3014
008803048319408632-3012
008803048319338632-3010
0088030480205614-525001E
0088030480204914-525000E
00888480499749LV00492
00887868309212LV01481
0088786825218107.00017.701
00887868381058LV01588
00887868381041LV01587
00887868342363LV01492
008884801450971200-9232
008884801418391200-1216
008884801418221200-1215
008884801418151200-1214
008884801418081200-1213
008884801417921200-1212
008884801417851200-1211
008884801417781200-1210
008884801417611200-1206
008884801417471200-1204
008884801417231200-1202
00887868275814LV01490
00887868275807LV01489
00887868275791LV01488
00887868275784LV01487
00887868275777LV01486
00887868275760LV01485
00887868275753LV01484
00887868243714LV01432
00887868224126LV01406
00887868224119LV01405
00887868224102LV01404
00887868224096LV01403
008884806683438734-6120
008884806683368734-6118
008884806683298734-6117
008884806681768734-4271

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