Altus Spine Cervical Interbody Fusion System

GUDID 00843210131207

Rasp, W/Tab

Altus Spine, LLC

Polymeric spinal interbody fusion cage
Primary Device ID00843210131207
NIH Device Record Key585cd432-3303-46b4-b37a-b9860966179d
Commercial Distribution StatusIn Commercial Distribution
Brand NameAltus Spine Cervical Interbody Fusion System
Version Model Number210-3106
Company DUNS078331322
Company NameAltus 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 Datetrue
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(610)355-4156
EmailInfo@altus-spine.com

Device Dimensions

Height6 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100843210131207 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ODPIntervertebral fusion device with bone graft, cervical

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00843210131207]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-02-24
Device Publish Date2018-09-25

On-Brand Devices [Altus Spine Cervical Interbody Fusion System]

00843210131412Trial, W/Tab
00843210131405Trial, W/Tab
00843210131399Trial, W/Tab
00843210131382Trial, W/Tab
00843210131375Trial, W/Tab
00843210131368Trial, W/Tab
00843210131351Trial, W/Tab
00843210131344Trial, W/Tab
00843210131337Trial, No Tab
00843210131320Trial, No Tab
00843210131313Trial, No Tab
00843210131306Trial, No Tab
00843210131290Trial, No Tab
00843210131283Trial, No Tab
00843210131276Trial, No Tab
00843210131269Trial, No Tab
00843210131252Rasp, W/Tab
00843210131245Rasp, W/Tab
00843210131238Rasp, W/Tab
00843210131221Rasp, W/Tab
00843210131214Rasp, W/Tab
00843210131207Rasp, W/Tab
00843210131191Rasp, W/Tab
00843210131184Rasp, W/Tab
00843210131177Rasp, No Tab
00843210131160Rasp, No Tab
00843210131153Rasp, No Tab
00843210131146Rasp, No Tab
00843210131139Rasp, No Tab
00843210131122Rasp, No Tab
00843210131115Rasp, No Tab
00843210131108Rasp, No Tab
00843210131092ALR Inserter
00843210131085ALR Sizer W/Tab
00843210131078ALR Sizer W/Tab
00843210131061ALR Sizer W/Tab
00843210131054ALR Sizer W/Tab
00843210131047ALR Sizer W/Tab
00843210131030ALR Sizer W/Tab
00843210131023ALR Sizer W/Tab
00843210131016ALR Inserter
00843210131009ALR Sizer, No Tab
00843210130996ALR Sizer, No Tab
00843210130989ALR Sizer, No Tab
00843210130972ALR Sizer, No Tab
00843210130965ALR Sizer, No Tab
00843210130958ALR Sizer, No Tab
00843210130941ALR Sizer, No Tab
00843210130934ALR Sizer, No Tab

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