Calix Spinal Implant System

GUDID M697X0340176PCSTR1

22mm L x 10mm W x 11mm H; Calix-PLIF, PC

X-SPINE SYSTEMS, INC.

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Primary Device IDM697X0340176PCSTR1
NIH Device Record Keyb6172e85-f0e9-457f-a724-f68203f4dd5b
Commercial Distribution StatusIn Commercial Distribution
Brand NameCalix Spinal Implant System
Version Model NumberX034-0176PC-STR
Company DUNS610042587
Company NameX-SPINE SYSTEMS, INC.
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 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 (888) 886-9354
EmailCS@xtantmedical.com
Phone+1 (888) 886-9354
EmailCS@xtantmedical.com
Phone+1 (888) 886-9354
EmailCS@xtantmedical.com
Phone+1 (888) 886-9354
EmailCS@xtantmedical.com
Phone+1 (888) 886-9354
EmailCS@xtantmedical.com
Phone+1 (888) 886-9354
EmailCS@xtantmedical.com
Phone+1 (888) 886-9354
EmailCS@xtantmedical.com
Phone+1 (888) 886-9354
EmailCS@xtantmedical.com
Phone+1 (888) 886-9354
EmailCS@xtantmedical.com
Phone+1 (888) 886-9354
EmailCS@xtantmedical.com
Phone+1 (888) 886-9354
EmailCS@xtantmedical.com
Phone+1 (888) 886-9354
EmailCS@xtantmedical.com
Phone+1 (888) 886-9354
EmailCS@xtantmedical.com
Phone+1 (888) 886-9354
EmailCS@xtantmedical.com
Phone+1 (888) 886-9354
EmailCS@xtantmedical.com
Phone+1 (888) 886-9354
EmailCS@xtantmedical.com

Device Dimensions

Length22 Millimeter
Height11 Millimeter
Width10 Millimeter
Length22 Millimeter
Height11 Millimeter
Width10 Millimeter
Length22 Millimeter
Height11 Millimeter
Width10 Millimeter
Length22 Millimeter
Height11 Millimeter
Width10 Millimeter
Length22 Millimeter
Height11 Millimeter
Width10 Millimeter
Length22 Millimeter
Height11 Millimeter
Width10 Millimeter
Length22 Millimeter
Height11 Millimeter
Width10 Millimeter
Length22 Millimeter
Height11 Millimeter
Width10 Millimeter
Length22 Millimeter
Height11 Millimeter
Width10 Millimeter
Length22 Millimeter
Height11 Millimeter
Width10 Millimeter
Length22 Millimeter
Height11 Millimeter
Width10 Millimeter
Length22 Millimeter
Height11 Millimeter
Width10 Millimeter
Length22 Millimeter
Height11 Millimeter
Width10 Millimeter
Length22 Millimeter
Height11 Millimeter
Width10 Millimeter
Length22 Millimeter
Height11 Millimeter
Width10 Millimeter
Length22 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM697X0340176PCSTR1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-10-21
Device Publish Date2019-10-11

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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