TLS 5.0

GUDID B030CX3010130

Interbody Fusion Device 7DEG x30L x 10W x13H

CAMBER SPINE TECHNOLOGIES, LLC

Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage
Primary Device IDB030CX3010130
NIH Device Record Key081a4a7b-4efe-4cfc-98a8-39f496632993
Commercial Distribution StatusIn Commercial Distribution
Brand NameTLS 5.0
Version Model NumberCX-301013
Company DUNS054205979
Company NameCAMBER SPINE TECHNOLOGIES, 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

Phone1-866-643-0739
Emailcustomerservice@cambermedtech.com
Phone1-866-643-0739
Emailcustomerservice@cambermedtech.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB030CX3010130 [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

[B030CX3010130]

Moist Heat or Steam Sterilization


[B030CX3010130]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-02-24
Device Publish Date2016-10-27

On-Brand Devices [TLS 5.0]

B030CX3010150Interbody Fusion Device 7DEG x30L x 10W x15H
B030CX3010140Interbody Fusion Device 7DEG x30L x 10W x14H
B030CX3010130Interbody Fusion Device 7DEG x30L x 10W x13H
B030CX3010120Interbody Fusion Device 7DEG x30L x 10W x12H
B030CX3010110Interbody Fusion Device 7DEG x30L x 10W x11H
B030CX3010100Interbody Fusion Device 7DEG x30L x 10W x10H
B030CX3010090Interbody Fusion Device 7DEG x30L x 10W x9H
B030CX3010080Interbody Fusion Device 7DEG x30L x 10W x8H
B030CX3010070Interbody Fusion Device 7DEG x30L x 10W x7H
B030CX2610150Interbody Fusion Device 7DEG x 26L x 10W x 15H
B030CX2610140Interbody Fusion Device 7DEG x 26L x 10W x 14H
B030CX2610130Interbody Fusion Device 7DEG x 26L x 10W x 13H
B030CX2610120Interbody Fusion Device 7DEG x 26L x 10W x 12H
B030CX2610110Interbody Fusion Device 7DEG x 26L x 10W x 11H
B030CX2610100Interbody Fusion Device 7DEG x 26L x 10W x 10H
B030CX2610090Interbody Fusion Device 7DEG x 26L x 10W x 9H
B030CX2610080Interbody Fusion Device 7DEG x 26L x 10W x 8H
B030CX2610070Interbody Fusion Device 7DEG x 26L x 10W x 7H
B030CX2210150Interbody Fusion Device 7DEG x 22L x 10W x 15H
B030CX2210140Interbody Fusion Device 7DEG x 22L x 10W x 14H
B030CX2210130Interbody Fusion Device 7DEG x 22L x 10W x 13H
B030CX2210120Interbody Fusion Device 7DEG x 22L x 10W x 12H
B030CX2210110Interbody Fusion Device 7DEG x 22L x 10W x 11H
B030CX2210100Interbody Fusion Device 7DEG x 22L x 10W x 10H
B030CX2210090Interbody Fusion Device 7DEG x 22L x 10W x 9H
B030CX2210080Interbody Fusion Device 7DEG x 22L x 10W x 8H
B030CX2210070Interbody Fusion Device 7DEG x 22L x 10W x 7H
B030CK2810150Enhanced Graft Interbody Cage 7DEG x 28L x 10W x 15H
B030CK2810140Enhanced Graft Interbody Cage 7DEG x 28L x 10W x 14H
B030CK2810130Enhanced Graft Interbody Cage 7DEG x 28L x 10W x 13H
B030CK2810120Enhanced Graft Interbody Cage 7DEG x 28L x 10W x 12H
B030CK2810110Enhanced Graft Interbody Cage 7DEG x 28L x 10W x 11H
B030CK2810100Enhanced Graft Interbody Cage 7DEG x 28L x 10W x 10H
B030CK2810090Enhanced Graft Interbody Cage 7DEG x 28L x 10W x 9H
B030CK2810080Enhanced Graft Interbody Cage 7DEG x 28L x 10W x 8H
B030CK2810070Enhanced Graft Interbody Cage 7DEG x 28L x 10W x 7H
B030CK2412150Enhanced Graft Interbody Cage 7DEG x 24L x 12W x 15H
B030CK2412140Enhanced Graft Interbody Cage 7DEG x 24L x 12W x 14H
B030CK2412130Enhanced Graft Interbody Cage 7DEG x 24L x 12W x 13H
B030CK2412120Enhanced Graft Interbody Cage 7DEG x 24L x 12W x 12H
B030CK2412110Enhanced Graft Interbody Cage 7DEG x 24L x 12W x 11H
B030CK2412100Enhanced Graft Interbody Cage 7DEG x 24L x 12W x 10H
B030CK2412090Enhanced Graft Interbody Cage 7DEG x 24L x 12W x 9H
B030CK2412080Enhanced Graft Interbody Cage 7DEG x 24L x 12W x 8H
B030CK2412070Enhanced Graft Interbody Cage 7DEG x 24L x 12W x 7H
B030CK2212150Enhanced Graft Interbody Cage 7DEG x 22L x 12W x 15H
B030CK2212140Enhanced Graft Interbody Cage 7DEG x 22L x 12W x 14H
B030CK2212130Enhanced Graft Interbody Cage 7DEG x 22L x 12W x 13H
B030CK2212120Enhanced Graft Interbody Cage 7DEG x 22L x 12W x 12H
B030CK2212110Enhanced Graft Interbody Cage 7DEG x 22L x 12W x 11H

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