Altus Spine Interbody Fusion System

GUDID 00843210130323

Implant Inserter

Altus Spine, LLC

Polymeric spinal interbody fusion cage
Primary Device ID00843210130323
NIH Device Record Keyb106d8bb-7ece-449c-957e-1f9b353e2c29
Commercial Distribution StatusIn Commercial Distribution
Brand NameAltus Spine Interbody Fusion System
Version Model Number1000-0300S
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 Identifiers

Device Issuing AgencyDevice ID
GS100843210130323 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral fusion device with bone graft, lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00843210130323]

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 Interbody Fusion System]

00843210131894Trial
00843210131887Trial
00843210131870Trial
00843210131863Trial
00843210131856Trial
00843210131849Trial
00843210131832Trial
00843210131825Trial
00843210131818Trial
00843210131801Trial
00843210131795Trial
00843210131788Implant Inserter
00843210131771Inserter with Tabs
00843210131764Implant Inserter
00843210131757Trial
00843210131740Trial
00843210131733Trial
00843210131726Trial
00843210131719Trial
00843210131702Trial
00843210131696Trial
00843210131689T-Handle Implant Inserter
00843210131672Broach Trial
00843210131665Broach Trial
00843210131658Broach Trial
00843210131641Broach Trial
00843210131634Broach Trial
00843210131627Broach Trial
00843210131610Broach Trial
00843210131603Broach Trial
00843210131597Broach Trial
00843210131580Broach Trial
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00843210131542Trial Spacer
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0084321013092726/30mm Paddle Sizer, Angled
0084321013091026/30mm Paddle Sizer, Angled

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