CEZANNE Lumbar Interbody Fusion Cage System

GUDID 00841732110960

CEZANNE™ PLIF PEEK Cage, 0Deg., W11 x L28, H8mm

CTL MEDICAL CORPORATION

Polymeric spinal interbody fusion cage

Primary Device ID	00841732110960
NIH Device Record Key	8d8ac5e6-a5ee-43f7-b6a1-ebb32697920d
Commercial Distribution Status	In Commercial Distribution
Brand Name	CEZANNE Lumbar Interbody Fusion Cage System
Version Model Number	017.0408
Company DUNS	080138504
Company Name	CTL MEDICAL CORPORATION
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

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

Device Dimensions

Height	8 Millimeter
Height	8 Millimeter
Height	8 Millimeter
Height	8 Millimeter
Width	11 Millimeter
Device Size Text, specify	0
Length	28 Millimeter
Height	8 Millimeter
Width	11 Millimeter
Device Size Text, specify	0
Length	28 Millimeter
Height	8 Millimeter
Width	11 Millimeter
Device Size Text, specify	0
Length	28 Millimeter
Height	8 Millimeter
Width	11 Millimeter
Device Size Text, specify	0
Length	28 Millimeter
Height	8 Millimeter
Width	11 Millimeter
Device Size Text, specify	0
Length	28 Millimeter
Height	8 Millimeter
Width	11 Millimeter
Device Size Text, specify	0
Length	28 Millimeter
Height	8 Millimeter
Width	11 Millimeter
Device Size Text, specify	0
Length	28 Millimeter
Height	8 Millimeter
Width	11 Millimeter
Device Size Text, specify	0
Length	28 Millimeter
Height	8 Millimeter
Width	11 Millimeter
Device Size Text, specify	0
Length	28 Millimeter
Height	8 Millimeter
Width	11 Millimeter
Device Size Text, specify	0
Length	28 Millimeter
Height	8 Millimeter
Width	11 Millimeter
Device Size Text, specify	0
Length	28 Millimeter
Height	8 Millimeter
Width	11 Millimeter
Device Size Text, specify	0
Length	28 Millimeter
Height	8 Millimeter
Width	11 Millimeter
Device Size Text, specify	0
Length	28 Millimeter
Height	8 Millimeter
Width	11 Millimeter
Device Size Text, specify	0
Length	28 Millimeter
Height	8 Millimeter
Width	11 Millimeter
Device Size Text, specify	0
Length	28 Millimeter
Height	8 Millimeter
Width	11 Millimeter
Device Size Text, specify	0
Length	28 Millimeter
Height	8 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841732110960 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K121567

FDA Product Code

MAX	Intervertebral fusion device with bone graft, lumbar

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[00841732110960]

Moist Heat or Steam Sterilization

[00841732110960]

Moist Heat or Steam Sterilization

[00841732110960]

Moist Heat or Steam Sterilization

[00841732110960]

Moist Heat or Steam Sterilization

[00841732110960]

Moist Heat or Steam Sterilization

[00841732110960]

Moist Heat or Steam Sterilization

[00841732110960]

Moist Heat or Steam Sterilization

[00841732110960]

Moist Heat or Steam Sterilization

[00841732110960]

Moist Heat or Steam Sterilization

[00841732110960]

Moist Heat or Steam Sterilization

[00841732110960]

Moist Heat or Steam Sterilization

[00841732110960]

Moist Heat or Steam Sterilization

[00841732110960]

Moist Heat or Steam Sterilization

[00841732110960]

Moist Heat or Steam Sterilization

[00841732110960]

Moist Heat or Steam Sterilization

[00841732110960]

Moist Heat or Steam Sterilization

[00841732110960]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	4
Public Version Date	2020-02-24
Device Publish Date	2016-03-08

On-Brand Devices [CEZANNE Lumbar Interbody Fusion Cage System]

00841732111592	CEZANNE™ PLIF PEEK Cage, 8Deg., W11 x L32, H16mm
00841732111585	CEZANNE™ PLIF PEEK Cage, 8Deg., W11 x L32, H15mm
00841732111578	CEZANNE™ PLIF PEEK Cage, 8Deg., W11 x L32, H14mm
00841732111561	CEZANNE™ PLIF PEEK Cage, 8Deg., W11 x L32, H13mm
00841732111554	CEZANNE™ PLIF PEEK Cage, 8Deg., W11 x L32, H12mm
00841732111547	CEZANNE™ PLIF PEEK Cage, 8Deg., W11 x L32, H11mm
00841732111530	CEZANNE™ PLIF PEEK Cage, 8Deg., W11 x L32, H10mm
00841732111523	CEZANNE™ PLIF PEEK Cage, 8Deg., W11 x L32, H9mm
00841732111516	CEZANNE™ PLIF PEEK Cage, 8Deg., W11 x L32, H8mm
00841732111509	CEZANNE™ PLIF PEEK Cage, 8Deg., W11 x L32, H7mm
00841732111493	CEZANNE™ PLIF PEEK Cage, 8Deg., W11 x L32, H6mm
00841732111486	CEZANNE™ PLIF PEEK Cage, 4Deg., W11 x L32, H16mm
00841732111479	CEZANNE™ PLIF PEEK Cage, 4Deg., W11 x L32, H15mm
00841732111462	CEZANNE™ PLIF PEEK Cage, 4Deg., W11 x L32, H14mm
00841732111455	CEZANNE™ PLIF PEEK Cage, 4Deg., W11 x L32, H13mm
00841732111448	CEZANNE™ PLIF PEEK Cage, 4Deg., W11 x L32, H12mm
00841732111431	CEZANNE™ PLIF PEEK Cage, 4Deg., W11 x L32, H11mm
00841732111424	CEZANNE™ PLIF PEEK Cage, 4Deg., W11 x L32, H10mm
00841732111417	CEZANNE™ PLIF PEEK Cage, 4Deg., W11 x L32, H9mm
00841732111400	CEZANNE™ PLIF PEEK Cage, 4Deg., W11 x L32, H8mm
00841732111394	CEZANNE™ PLIF PEEK Cage, 4Deg., W11 x L32, H7mm
00841732111387	CEZANNE™ PLIF PEEK Cage, 4Deg., W11 x L32, H6mm
00841732111370	CEZANNE™ PLIF PEEK Cage, 0Deg., W11 x L32, H16mm
00841732111363	CEZANNE™ PLIF PEEK Cage, 0Deg., W11 x L32, H15mm
00841732111356	CEZANNE™ PLIF PEEK Cage, 0Deg., W11 x L32, H14mm
00841732111349	CEZANNE™ PLIF PEEK Cage, 0Deg., W11 x L32, H13mm
00841732111332	CEZANNE™ PLIF PEEK Cage, 0Deg., W11 x L32, H12mm
00841732111325	CEZANNE™ PLIF PEEK Cage, 0Deg., W11 x L32, H11mm
00841732111318	CEZANNE™ PLIF PEEK Cage, 0Deg., W11 x L32, H10mm
00841732111301	CEZANNE™ PLIF PEEK Cage, 0Deg., W11 x L32, H9mm
00841732111295	CEZANNE™ PLIF PEEK Cage, 0Deg., W11 x L32, H8mm
00841732111288	CEZANNE™ PLIF PEEK Cage, 0Deg., W11 x L32, H7mm
00841732111271	CEZANNE™ PLIF PEEK Cage, 0Deg., W11 x L32, H6mm
00841732111264	CEZANNE™ PLIF PEEK Cage, 8Deg., W11 x L28, H16mm
00841732111257	CEZANNE™ PLIF PEEK Cage, 8Deg., W11 x L28, H15mm
00841732111240	CEZANNE™ PLIF PEEK Cage, 8Deg., W11 x L28, H14mm
00841732111233	CEZANNE™ PLIF PEEK Cage, 8Deg., W11 x L28, H13mm
00841732111226	CEZANNE™ PLIF PEEK Cage, 8Deg., W11 x L28, H12mm
00841732111219	CEZANNE™ PLIF PEEK Cage, 8Deg., W11 x L28, H11mm
00841732111202	CEZANNE™ PLIF PEEK Cage, 8Deg., W11 x L28, H10mm
00841732111196	CEZANNE™ PLIF PEEK Cage, 8Deg., W11 x L28, H9mm
00841732111189	CEZANNE™ PLIF PEEK Cage, 8Deg., W11 x L28, H8mm
00841732111172	CEZANNE™ PLIF PEEK Cage, 8Deg., W11 x L28, H7mm
00841732111165	CEZANNE™ PLIF PEEK Cage, 8Deg., W11 x L28, H6mm
00841732111158	CEZANNE™ PLIF PEEK Cage, 4Deg., W11 x L28, H16mm
00841732111141	CEZANNE™ PLIF PEEK Cage, 4Deg., W11 x L28, H15mm
00841732111134	CEZANNE™ PLIF PEEK Cage, 4Deg., W11 x L28, H14mm
00841732111127	CEZANNE™ PLIF PEEK Cage, 4Deg., W11 x L28, H13mm
00841732111110	CEZANNE™ PLIF PEEK Cage, 4Deg., W11 x L28, H12mm
00841732111103	CEZANNE™ PLIF PEEK Cage, 4Deg., W11 x L28, H11mm

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