CEZANNE II

GUDID 00841732129368

CEZANNE-II™ DLIF PEEK Cage, 8Deg., W19 x L50, H14mm

CTL MEDICAL CORPORATION

Polymeric spinal interbody fusion cage
Primary Device ID00841732129368
NIH Device Record Key4b485be6-c622-4713-8556-efadd23bd356
Commercial Distribution StatusIn Commercial Distribution
Brand NameCEZANNE II
Version Model Number018.3214
Company DUNS080138504
Company NameCTL MEDICAL CORPORATION
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100841732129368 [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

[00841732129368]

Moist Heat or Steam Sterilization


[00841732129368]

Moist Heat or Steam Sterilization


[00841732129368]

Moist Heat or Steam Sterilization


[00841732129368]

Moist Heat or Steam Sterilization


[00841732129368]

Moist Heat or Steam Sterilization


[00841732129368]

Moist Heat or Steam Sterilization


[00841732129368]

Moist Heat or Steam Sterilization


[00841732129368]

Moist Heat or Steam Sterilization


[00841732129368]

Moist Heat or Steam Sterilization


[00841732129368]

Moist Heat or Steam Sterilization


[00841732129368]

Moist Heat or Steam Sterilization


[00841732129368]

Moist Heat or Steam Sterilization


[00841732129368]

Moist Heat or Steam Sterilization


[00841732129368]

Moist Heat or Steam Sterilization


[00841732129368]

Moist Heat or Steam Sterilization


[00841732129368]

Moist Heat or Steam Sterilization


[00841732129368]

Moist Heat or Steam Sterilization


[00841732129368]

Moist Heat or Steam Sterilization


[00841732129368]

Moist Heat or Steam Sterilization


[00841732129368]

Moist Heat or Steam Sterilization


[00841732129368]

Moist Heat or Steam Sterilization


[00841732129368]

Moist Heat or Steam Sterilization


[00841732129368]

Moist Heat or Steam Sterilization


[00841732129368]

Moist Heat or Steam Sterilization


[00841732129368]

Moist Heat or Steam Sterilization


[00841732129368]

Moist Heat or Steam Sterilization


[00841732129368]

Moist Heat or Steam Sterilization


[00841732129368]

Moist Heat or Steam Sterilization


[00841732129368]

Moist Heat or Steam Sterilization


[00841732129368]

Moist Heat or Steam Sterilization


[00841732129368]

Moist Heat or Steam Sterilization


[00841732129368]

Moist Heat or Steam Sterilization


[00841732129368]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-10-18
Device Publish Date2023-10-10

On-Brand Devices [CEZANNE II]

00841732139558CEZANNE-II™ DLIF PEEK Cage, 0Deg., W19 x L45, H11mm
00841732139541CEZANNE-II™ DLIF PEEK Cage, 0Deg., W19 x L45, H10mm
00841732139534CEZANNE-II™ DLIF PEEK Cage, 0Deg., W19 x L45, H9mm
00841732139527CEZANNE-II™ DLIF PEEK Cage, 0Deg., W19 x L45, H8mm
00841732139510CEZANNE-II™ DLIF PEEK Cage, 0Deg., W19 x L40, H16mm
00841732139503CEZANNE-II™ DLIF PEEK Cage, 0Deg., W19 x L40, H15mm
00841732139497CEZANNE-II™ DLIF PEEK Cage, 0Deg., W19 x L40, H14mm
00841732139480CEZANNE-II™ DLIF PEEK Cage, 0Deg., W19 x L40, H13mm
00841732137509CEZANNE-II™ DLIF PEEK Cage, 0Deg., W19 x L40, H12mm
00841732137493CEZANNE-II™ DLIF PEEK Cage, 0Deg., W19 x L40, H11mm
00841732137486CEZANNE-II™ DLIF PEEK Cage, 0Deg., W19 x L40, H10mm
00841732137462CEZANNE-II™ DLIF PEEK Cage, 0Deg., W19 x L40, H9mm
00841732134331CEZANNE-II™ DLIF PEEK Cage, 8Deg., W19 x L50, H15mm
00841732129368CEZANNE-II™ DLIF PEEK Cage, 8Deg., W19 x L50, H14mm
00841732128033CEZANNE-II™ DLIF PEEK Cage, 8Deg., W19 x L50, H13mm
00841732128002CEZANNE-II™ DLIF PEEK Cage, 8Deg., W19 x L50, H12mm
00841732127999CEZANNE-II™ DLIF PEEK Cage, 8Deg., W19 x L50, H11mm
00841732127982CEZANNE-II™ DLIF PEEK Cage, 8Deg., W19 x L50, H10mm
00841732125407CEZANNE-II™ DLIF PEEK Cage, 0Deg., W19 x L40, H8mm
00841732114678CEZANNE-II™ DLIF PEEK Cage, 8Deg., W19 x L45, H15mm
00841732114661CEZANNE-II™ DLIF PEEK Cage, 8Deg., W19 x L45, H16mm
00841732114654CEZANNE-II™ DLIF PEEK Cage, 8Deg., W19 x L50, H9mm
00841732114647CEZANNE-II™ DLIF PEEK Cage, 0Deg., W19 x L55, H8mm
00841732114630CEZANNE-II™ DLIF PEEK Cage, 8Deg., W19 x L45, H14mm
00841732114623CEZANNE-II™ DLIF PEEK Cage, 8Deg., W19 x L50, H8mm
00841732114616CEZANNE-II™ DLIF PEEK Cage, 0Deg., W19 x L50, H16mm
00841732114609CEZANNE-II™ DLIF PEEK Cage, 8Deg., W19 x L45, H12mm
00841732114593CEZANNE-II™ DLIF PEEK Cage, 8Deg., W19 x L45, H13mm
00841732144637CEZANNE-II™ DLIF PEEK Cage, 0Deg., W19 x L55, H10mm
00841732140943CEZANNE-II™ DLIF PEEK Cage, 8Deg., W19 x L50, H16mm
00841732139756CEZANNE-II™ DLIF PEEK Cage, 0Deg., W19 x L50, H11mm
00841732139633CEZANNE-II™ DLIF PEEK Cage, 0Deg., W19 x L50, H10mm
00841732139626CEZANNE-II™ DLIF PEEK Cage, 0Deg., W19 x L50, H9mm
00841732139619CEZANNE-II™ DLIF PEEK Cage, 0Deg., W19 x L50, H8mm
00841732139602CEZANNE-II™ DLIF PEEK Cage, 0Deg., W19 x L45, H16mm
00841732139596CEZANNE-II™ DLIF PEEK Cage, 0Deg., W19 x L45, H15mm
00841732139589CEZANNE-II™ DLIF PEEK Cage, 0Deg., W19 x L45, H14mm
00841732139572CEZANNE-II™ DLIF PEEK Cage, 0Deg., W19 x L45, H13mm
00841732139565CEZANNE-II™ DLIF PEEK Cage, 0Deg., W19 x L45, H12mm

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