Calix Spinal Implant System

GUDID M697C03402120

12MM SPECIALTY PADDLE STYLE TRIAL ASSEMBLY

X-SPINE SYSTEMS, INC.

Polymeric spinal interbody fusion cage
Primary Device IDM697C03402120
NIH Device Record Key191d104f-6dbc-4a01-b20e-f14b656a1956
Commercial Distribution StatusIn Commercial Distribution
Brand NameCalix Spinal Implant System
Version Model NumberC034-0212
Company DUNS610042587
Company NameX-SPINE SYSTEMS, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
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(937)847-8400
Emailorders@x-spine.com
Phone+1(937)847-8400
Emailorders@x-spine.com
Phone+1(937)847-8400
Emailorders@x-spine.com
Phone+1(937)847-8400
Emailorders@x-spine.com
Phone+1(937)847-8400
Emailorders@x-spine.com
Phone+1(937)847-8400
Emailorders@x-spine.com
Phone+1(937)847-8400
Emailorders@x-spine.com
Phone+1(937)847-8400
Emailorders@x-spine.com
Phone+1(937)847-8400
Emailorders@x-spine.com
Phone+1(937)847-8400
Emailorders@x-spine.com
Phone+1(937)847-8400
Emailorders@x-spine.com
Phone+1(937)847-8400
Emailorders@x-spine.com
Phone+1(937)847-8400
Emailorders@x-spine.com
Phone+1(937)847-8400
Emailorders@x-spine.com
Phone+1(937)847-8400
Emailorders@x-spine.com
Phone+1(937)847-8400
Emailorders@x-spine.com

Device Dimensions

Height12 Millimeter
Height12 Millimeter
Height12 Millimeter
Height12 Millimeter
Height12 Millimeter
Height12 Millimeter
Height12 Millimeter
Height12 Millimeter
Height12 Millimeter
Height12 Millimeter
Height12 Millimeter
Height12 Millimeter
Height12 Millimeter
Height12 Millimeter
Height12 Millimeter
Height12 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM697C03402120 [Direct Marking]
HIBCCM697C03402121 [Primary]

FDA Product Code

HWTTEMPLATE

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M697C03402120]

Moist Heat or Steam Sterilization

[M697C03402120]

Moist Heat or Steam Sterilization

[M697C03402120]

Moist Heat or Steam Sterilization

[M697C03402120]

Moist Heat or Steam Sterilization

[M697C03402120]

Moist Heat or Steam Sterilization

[M697C03402120]

Moist Heat or Steam Sterilization

[M697C03402120]

Moist Heat or Steam Sterilization

[M697C03402120]

Moist Heat or Steam Sterilization

[M697C03402120]

Moist Heat or Steam Sterilization

[M697C03402120]

Moist Heat or Steam Sterilization

[M697C03402120]

Moist Heat or Steam Sterilization

[M697C03402120]

Moist Heat or Steam Sterilization

[M697C03402120]

Moist Heat or Steam Sterilization

[M697C03402120]

Moist Heat or Steam Sterilization

[M697C03402120]

Moist Heat or Steam Sterilization

[M697C03402120]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-02-24
Device Publish Date2016-03-29

On-Brand Devices [Calix Spinal Implant System]

M697X0340397PCSTR126mm L x 10mm W x 16mm H; 5° Calix-PLIF, PC
M697X0340396PCSTR126mm L x 10mm W x 15mm H; 5° Calix-PLIF, PC
M697X0340395PCSTR126mm L x 10mm W x 14mm H; 5° Calix-PLIF, PC
M697X0340394PCSTR126mm L x 10mm W x 13mm H; 5° Calix-PLIF, PC
M697X0340393PCSTR126mm L x 10mm W x 12mm H; 5° Calix-PLIF, PC
M697X0340392PCSTR126mm L x 10mm W x 11mm H; 5° Calix-PLIF, PC
M697X0340391PCSTR126mm L x 10mm W x 10mm H; 5° Calix-PLIF, PC
M697X0340390PCSTR126mm L x 10mm W x 9mm H; 5° Calix-PLIF, PC
M697X0340389PCSTR126mm L x 10mm W x 8mm H; 5° Calix-PLIF, PC
M697X0340388PCSTR126mm L x 10mm W x 7mm H; 5° Calix-PLIF, PC
M697X0340387PCSTR126mm L x 10mm W x 6mm H; 5° Calix-PLIF, PC
M697X0340290PCSTR128mm x 10mm x 16mm Calix-TLIF, PC
M697X0340289PCSTR128mm x 10mm x 15mm Calix-TLIF, PC
M697X0340288PCSTR128mm x 10mm x 14mm Calix-TLIF, PC
M697X0340287PCSTR128mm x 10mm x 13mm Calix-TLIF, PC
M697X0340286PCSTR128mm x 10mm x 12mm Calix-TLIF, PC
M697X0340285PCSTR128mm x 10mm x 11mm Calix-TLIF, PC
M697X0340284PCSTR128mm x 10mm x 10mm Calix-TLIF, PC
M697X0340283PCSTR128mm x 10mm x 9mm Calix-TLIF, PC
M697X0340282PCSTR128mm x 10mm x 8mm Calix-TLIF, PC
M697X0340281PCSTR128mm x 10mm x 7mm Calix-TLIF, PC
M697X0340280PCSTR128mm x 10mm x 6mm Calix-TLIF, PC
M697X0340253PCSTR126mm L x 10mm W x 16mm H; Calix-PLIF, PC
M697X0340249PCSTR126mm L x 10mm W x 15mm H; Calix-PLIF, PC
M697X0340248PCSTR126mm L x 10mm W x 13mm H; Calix-PLIF, PC
M697X0340247PCSTR126mm L x 10mm W x 11mm H; Calix-PLIF, PC
M697X0340246PCSTR126mm L x 10mm W x 9mm H; Calix-PLIF, PC
M697X0340245PCSTR126mm L x 10mm W x 7mm H; Calix-PLIF, PC
M697X0340244PCSTR126mm L x 10mm W x 14mm H; Calix-PLIF, PC
M697X0340243PCSTR126mm L x 10mm W x 12mm H; Calix-PLIF, PC
M697X0340242PCSTR126mm L x 10mm W x 10mm H; Calix-PLIF, PC
M697X0340241PCSTR126mm L x 10mm W x 8mm H; Calix-PLIF, PC
M697X0340240PCSTR126mm L x 10mm W x 6mm H; Calix-PLIF, PC
M697X0340181PCSTR122mm L x 10mm W x 16mm H; Calix-PLIF, PC
M697X0340180PCSTR122mm L x 10mm W x 15mm H; Calix-PLIF, PC
M697X0340179PCSTR122mm L x 10mm W x 14mm H; Calix-PLIF, PC
M697X0340178PCSTR122mm L x 10mm W x 13mm H; Calix-PLIF, PC
M697X0340177PCSTR122mm L x 10mm W x 12mm H; Calix-PLIF, PC
M697X0340176PCSTR122mm L x 10mm W x 11mm H; Calix-PLIF, PC
M697X0340175PCSTR122mm L x 10mm W x 10mm H; Calix-PLIF, PC
M697X0340174PCSTR122mm L x 10mm W x 9mm H; Calix-PLIF, PC
M697X0340173PCSTR122mm L x 10mm W x 8mm H; Calix-PLIF, PC
M697X0340172PCSTR122mm L x 10mm W x 7mm H; Calix-PLIF, PC
M697X0340171PCSTR122mm L x 10mm W x 6mm H; Calix-PLIF, PC
M697X0342890026mm x 10mm x 16mm PLIF RASP ASSY
M697X0342889026mm x 10mm x 15mm PLIF RASP ASSY
M697X0342888026mm x 10mm x 14mm PLIF RASP ASSY
M697X0342887026mm x 10mm x 13mm PLIF RASP ASSY
M697X0342886026mm x 10mm x 12mm PLIF RASP ASSY
M697X0342885026mm x 10mm x 11mm PLIF RASP ASSY
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