EVOL Lumbar Interbody System CPB15015

GUDID 00841193103006

15mm X 12mm X 32mm Parallel CLIF Cage

Cutting Edge Spine, LLC

Polymeric spinal interbody fusion cage
Primary Device ID00841193103006
NIH Device Record Key0ac2f01f-40eb-4b25-8732-30f1847ee859
Commercial Distribution StatusIn Commercial Distribution
Brand NameEVOL Lumbar Interbody System
Version Model NumberCPB15015
Catalog NumberCPB15015
Company DUNS069472647
Company NameCutting Edge Spine, LLC
Device Count1
DM Exempttrue
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(704)243-0892
EmailB.Roof@cuttingedgespine.com

Device Dimensions

Length32 Millimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature

Device Identifiers

Device Issuing AgencyDevice ID
GS100841193103006 [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

[00841193103006]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-02-24
Device Publish Date2015-10-30

On-Brand Devices [EVOL Lumbar Interbody System]

00841193103082EVOL Straight Lateral Inserter
00841193103075EVOL Straight PLIF Inserter
008411931204547X9mm,X 10mm X 23 mm Lordotic LIF Cage
0084119312044717 X 20 X 55 mm RLIF Cage
0084119312043016 X 20 X 55 mm RLIF Cage
0084119312042315 X 20 X 55 mm RLIF Cage
0084119312041614 X 20 X 55 mm RLIF Cage
0084119312040913 X 20 X 55 mm RLIF Cage
008411931203937 X 20 X 55 mm RLIF Cage
0084119312038617 X 20 X 40 mm RLIF Cage
0084119312037916 X 20 X 40 mm RLIF Cage
0084119312036215 X 20 X 40 mm RLIF Cage
0084119312035514 X 20 X 40 mm RLIF Cage
0084119312034813 X 20 X 40 mm RLIF Cage
008411931203317 X 20 X 40 mm RLIF Cage
0084119312032417 X 20 X 45 mm RLIF Cage
0084119312031716 X 20 X 45 mm RLIF Cage
0084119312030015 X 20 X 45 mm RLIF Cage
0084119312029414 X 20 X 45 mm RLIF Cage
0084119312028713 X 20 X 45 mm RLIF Cage
008411931202707 X 20 X 45 mm RLIF Cage
008411931202637 X 20 X 50 mm RLIF Cage
0084119312025617 X 20 X 50 mm RLIF Cage
0084119312024916 X 20 X 50 mm RLIF Cage
0084119312023215 X 20 X 50 mm RLIF Cage
0084119312022514 X 20 X 50 mm RLIF Cage
0084119312021813 X 20 X 50 mm RLIF Cage
0084119311995312 X 20 X 40 mm RLIF Cage
0084119311994611 X 20 X 40 mm RLIF Cage
0084119311993910 X 20 X 40 mm RLIF Cage
008411931199229 X 20 X 40 mm RLIF Cage
008411931199158 X 20 X 40 mm RLIF Cage
0084119310303716mm X 12mm X 28mm Parallel CLIF Cage
0084119310302015mm X 12mm X 28mm Parallel CLIF Cage
0084119310301316mm X 12mm X 32mm Parallel CLIF Cage
0084119310300615mm X 12mm X 32mm Parallel CLIF Cage
0084119310299314mm X 12mm X 32mm Parallel CLIF Cage
0084119310298613mm X 12mm X 32mm Parallel CLIF Cage
0084119310297912mm X 12mm X 32mm Parallel CLIF Cage
0084119310296211mm X 12mm X 32mm Parallel CLIF Cage
0084119310295510mm X 12mm X 32mm Parallel CLIF Cage
008411931029489mm X 12mm X 32mm Parallel CLIF Cage
008411931029318mm X 12mm X 32mm Parallel CLIF Cage
0084119310292414mm X 12mm X 28mm Parallel CLIF Cage
0084119310291713mm X 12mm X 28mm Parallel CLIF Cage
0084119310290012mm X 12mm X 28mm Parallel CLIF Cage
0084119310289411mm X 12mm X 28mm Parallel CLIF Cage
0084119310288710mm X 12mm X 28mm Parallel CLIF Cage
008411931028709mm X 12mm X 28mm Parallel CLIF Cage
008411931028638mm X 12mm X 28mm Parallel CLIF Cage

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