Imola Titanium Interbody Fusion System

GUDID B417F1264012T1

10degree Lateral Interbody Fusion, Titanium Imola - L

Altus Spine, LLC

Metallic spinal fusion cage, non-sterile Metallic spinal fusion cage, non-sterile
Primary Device IDB417F1264012T1
NIH Device Record Key6fc1e922-6b8f-4631-9079-405ac1ef31c9
Commercial Distribution StatusIn Commercial Distribution
Brand NameImola Titanium Interbody Fusion System
Version Model NumberF12640-12T
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 Usetrue
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
Phone+1(610)355-4156
EmailInfo@altus-spine.com

Device Dimensions

Width26 Millimeter
Length40 Millimeter
Height12 Millimeter
Angle10 degree
Width26 Millimeter
Length40 Millimeter
Height12 Millimeter
Angle10 degree

Device Identifiers

Device Issuing AgencyDevice ID
GS100843210105642 [Secondary]
HIBCCB417F1264012T1 [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

[B417F1264012T1]

Moist Heat or Steam Sterilization


[B417F1264012T1]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-08-22

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B417F6305008T16degree Lateral Interbody Fusion, Titanium Imola - L
B417F6304508T16degree Lateral Interbody Fusion, Titanium Imola - L
B417F6304008T16degree Lateral Interbody Fusion, Titanium Imola - L
B417F6266008T16degree Lateral Interbody Fusion, Titanium Imola - L
B417F6265508T16degree Lateral Interbody Fusion, Titanium Imola - L
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B417F6264508T16degree Lateral Interbody Fusion, Titanium Imola - L
B417F6264008T16degree Lateral Interbody Fusion, Titanium Imola - L
B417F6226008T16degree Lateral Interbody Fusion, Titanium Imola - L
B417F6225508T16degree Lateral Interbody Fusion, Titanium Imola - L
B417F6225008T16degree Lateral Interbody Fusion, Titanium Imola - L
B417F6224508T16degree Lateral Interbody Fusion, Titanium Imola - L
B417F6224008T16degree Lateral Interbody Fusion, Titanium Imola - L
B417F6186008T16degree Lateral Interbody Fusion, Titanium Imola - L
B417F6185508T16degree Lateral Interbody Fusion, Titanium Imola - L
B417F6185008T16degree Lateral Interbody Fusion, Titanium Imola - L
B417F6184508T16degree Lateral Interbody Fusion, Titanium Imola - L
B417F6184008T16degree Lateral Interbody Fusion, Titanium Imola - L
B417F1306016T110degree Lateral Interbody Fusion, Titanium Imola - L
B417F1306014T110degree Lateral Interbody Fusion, Titanium Imola - L
B417F1306012T110degree Lateral Interbody Fusion, Titanium Imola - L
B417F1306010T110degree Lateral Interbody Fusion, Titanium Imola - L
B417F1305516T110degree Lateral Interbody Fusion, Titanium Imola - L
B417F1305514T110degree Lateral Interbody Fusion, Titanium Imola - L
B417F1305512T110degree Lateral Interbody Fusion, Titanium Imola - L
B417F1305510T110degree Lateral Interbody Fusion, Titanium Imola - L
B417F1305016T110degree Lateral Interbody Fusion, Titanium Imola - L
B417F1305014T110degree Lateral Interbody Fusion, Titanium Imola - L
B417F1305012T110degree Lateral Interbody Fusion, Titanium Imola - L
B417F1305010T110degree Lateral Interbody Fusion, Titanium Imola - L
B417F1304516T110degree Lateral Interbody Fusion, Titanium Imola - L
B417F1304514T110degree Lateral Interbody Fusion, Titanium Imola - L
B417F1304512T110degree Lateral Interbody Fusion, Titanium Imola - L
B417F1304510T110degree Lateral Interbody Fusion, Titanium Imola - L
B417F1304016T110degree Lateral Interbody Fusion, Titanium Imola - L
B417F1304014T110degree Lateral Interbody Fusion, Titanium Imola - L
B417F1304012T110degree Lateral Interbody Fusion, Titanium Imola - L
B417F1304010T110degree Lateral Interbody Fusion, Titanium Imola - L
B417F1266016T110degree Lateral Interbody Fusion, Titanium Imola - L
B417F1266014T110degree Lateral Interbody Fusion, Titanium Imola - L
B417F1266012T110degree Lateral Interbody Fusion, Titanium Imola - L
B417F1266010T110degree Lateral Interbody Fusion, Titanium Imola - L
B417F1265516T110degree Lateral Interbody Fusion, Titanium Imola - L
B417F1265514T110degree Lateral Interbody Fusion, Titanium Imola - L
B417F1265512T110degree Lateral Interbody Fusion, Titanium Imola - L
B417F1265510T110degree Lateral Interbody Fusion, Titanium Imola - L
B417F1265016T110degree Lateral Interbody Fusion, Titanium Imola - L
B417F1265014T110degree Lateral Interbody Fusion, Titanium Imola - L

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