CEZANNE-II

GUDID 00841732125353

CTL MEDICAL CORPORATION

Polymeric spinal interbody fusion cage
Primary Device ID00841732125353
NIH Device Record Key7d703f34-bb16-4a4c-827e-c1e9fef1db1d
Commercial Distribution StatusIn Commercial Distribution
Brand NameCEZANNE-II
Version Model Number128.4032
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(214)545-5820
Emailcomplaints@ctlmed.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100841732125353 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral fusion device with bone graft, lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00841732125353]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-02-24
Device Publish Date2019-10-28

On-Brand Devices [CEZANNE-II]

00841732123977018.5314
00841732123960018.5312
00841732123953018.5310
00841732123946018.5214
00841732123939018.5212
00841732123922018.5210
00841732123915018.5114
00841732123908018.5112
00841732123892018.5110
00841732125384128.4035
00841732125377128.4034
00841732125360128.4033
00841732125353128.4032
00841732125346128.4031
00841732125339128.4030
00841732125322128.4029
00841732125315128.4028
00841732124981128.5430
00841732124974128.5429
00841732124967128.5428
00841732124950128.5330
00841732124943128.5329
00841732124936128.5328
00841732123700128.5230
00841732123694128.5229
00841732123687128.5228

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