Calix Spinal Implant System

GUDID M697X0340247PCSTR1

26mm L x 10mm W x 11mm H; Calix-PLIF, PC

X-SPINE SYSTEMS, INC.

Polymeric spinal fusion cage, sterile

Primary Device ID	M697X0340247PCSTR1
NIH Device Record Key	e42f332c-b615-43eb-ad25-ef943b612e22
Commercial Distribution Status	In Commercial Distribution
Brand Name	Calix Spinal Implant System
Version Model Number	X034-0247PC-STR
Company DUNS	610042587
Company Name	X-SPINE SYSTEMS, INC.
Device Count	1
DM Exempt	true
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 (888) 886-9354
Email	CS@xtantmedical.com
Phone	+1 (888) 886-9354
Email	CS@xtantmedical.com
Phone	+1 (888) 886-9354
Email	CS@xtantmedical.com
Phone	+1 (888) 886-9354
Email	CS@xtantmedical.com
Phone	+1 (888) 886-9354
Email	CS@xtantmedical.com
Phone	+1 (888) 886-9354
Email	CS@xtantmedical.com
Phone	+1 (888) 886-9354
Email	CS@xtantmedical.com
Phone	+1 (888) 886-9354
Email	CS@xtantmedical.com
Phone	+1 (888) 886-9354
Email	CS@xtantmedical.com
Phone	+1 (888) 886-9354
Email	CS@xtantmedical.com
Phone	+1 (888) 886-9354
Email	CS@xtantmedical.com
Phone	+1 (888) 886-9354
Email	CS@xtantmedical.com
Phone	+1 (888) 886-9354
Email	CS@xtantmedical.com
Phone	+1 (888) 886-9354
Email	CS@xtantmedical.com
Phone	+1 (888) 886-9354
Email	CS@xtantmedical.com
Phone	+1 (888) 886-9354
Email	CS@xtantmedical.com
Phone	+1(888)886-9354
Email	cs@xtantmedical.com
Phone	+1(888)886-9354
Email	cs@xtantmedical.com
Phone	+1(888)886-9354
Email	cs@xtantmedical.com
Phone	+1(888)886-9354
Email	cs@xtantmedical.com
Phone	+1(888)886-9354
Email	cs@xtantmedical.com
Phone	+1(888)886-9354
Email	cs@xtantmedical.com
Phone	+1(888)886-9354
Email	cs@xtantmedical.com
Phone	+1(888)886-9354
Email	cs@xtantmedical.com
Phone	+1(888)886-9354
Email	cs@xtantmedical.com
Phone	+1(888)886-9354
Email	cs@xtantmedical.com
Phone	+1(888)886-9354
Email	cs@xtantmedical.com
Phone	+1(888)886-9354
Email	cs@xtantmedical.com
Phone	+1(888)886-9354
Email	cs@xtantmedical.com
Phone	+1(888)886-9354
Email	cs@xtantmedical.com

Device Dimensions

Length	26 Millimeter
Height	11 Millimeter
Width	10 Millimeter
Length	26 Millimeter
Height	11 Millimeter
Width	10 Millimeter
Length	26 Millimeter
Height	11 Millimeter
Width	10 Millimeter
Length	26 Millimeter
Height	11 Millimeter
Width	10 Millimeter
Length	26 Millimeter
Height	11 Millimeter
Width	10 Millimeter
Length	26 Millimeter
Height	11 Millimeter
Width	10 Millimeter
Length	26 Millimeter
Height	11 Millimeter
Width	10 Millimeter
Length	26 Millimeter
Height	11 Millimeter
Width	10 Millimeter
Length	26 Millimeter
Height	11 Millimeter
Width	10 Millimeter
Length	26 Millimeter
Height	11 Millimeter
Width	10 Millimeter
Length	26 Millimeter
Height	11 Millimeter
Width	10 Millimeter
Length	26 Millimeter
Height	11 Millimeter
Width	10 Millimeter
Length	26 Millimeter
Height	11 Millimeter
Width	10 Millimeter
Length	26 Millimeter
Height	11 Millimeter
Width	10 Millimeter
Length	26 Millimeter
Height	11 Millimeter
Width	10 Millimeter
Length	26 Millimeter
Height	11 Millimeter
Width	10 Millimeter
Length	26 Millimeter
Height	11 Millimeter
Width	10 Millimeter
Length	26 Millimeter
Height	11 Millimeter
Width	10 Millimeter
Length	26 Millimeter
Height	11 Millimeter
Width	10 Millimeter
Length	26 Millimeter
Height	11 Millimeter
Width	10 Millimeter
Length	26 Millimeter
Height	11 Millimeter
Width	10 Millimeter
Length	26 Millimeter
Height	11 Millimeter
Width	10 Millimeter
Length	26 Millimeter
Height	11 Millimeter
Width	10 Millimeter
Length	26 Millimeter
Height	11 Millimeter
Width	10 Millimeter
Length	26 Millimeter
Height	11 Millimeter
Width	10 Millimeter
Length	26 Millimeter
Height	11 Millimeter
Width	10 Millimeter
Length	26 Millimeter
Height	11 Millimeter
Width	10 Millimeter
Length	26 Millimeter
Height	11 Millimeter
Width	10 Millimeter
Length	26 Millimeter
Height	11 Millimeter
Width	10 Millimeter
Length	26 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M697X0340247PCSTR1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K170119

FDA Product Code

MAX	Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

[M697X0340247PCSTR1]

Radiation Sterilization

[M697X0340247PCSTR1]

Radiation Sterilization

[M697X0340247PCSTR1]

Radiation Sterilization

[M697X0340247PCSTR1]

Radiation Sterilization

[M697X0340247PCSTR1]

Radiation Sterilization

[M697X0340247PCSTR1]

Radiation Sterilization

[M697X0340247PCSTR1]

Radiation Sterilization

[M697X0340247PCSTR1]

Radiation Sterilization

[M697X0340247PCSTR1]

Radiation Sterilization

[M697X0340247PCSTR1]

Radiation Sterilization

[M697X0340247PCSTR1]

Radiation Sterilization

[M697X0340247PCSTR1]

Radiation Sterilization

[M697X0340247PCSTR1]

Radiation Sterilization

[M697X0340247PCSTR1]

Radiation Sterilization

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2019-10-21
Device Publish Date	2019-10-11

On-Brand Devices [Calix Spinal Implant System]

M697X0340397PCSTR1	26mm L x 10mm W x 16mm H; 5° Calix-PLIF, PC
M697X0340396PCSTR1	26mm L x 10mm W x 15mm H; 5° Calix-PLIF, PC
M697X0340395PCSTR1	26mm L x 10mm W x 14mm H; 5° Calix-PLIF, PC
M697X0340394PCSTR1	26mm L x 10mm W x 13mm H; 5° Calix-PLIF, PC
M697X0340393PCSTR1	26mm L x 10mm W x 12mm H; 5° Calix-PLIF, PC
M697X0340392PCSTR1	26mm L x 10mm W x 11mm H; 5° Calix-PLIF, PC
M697X0340391PCSTR1	26mm L x 10mm W x 10mm H; 5° Calix-PLIF, PC
M697X0340390PCSTR1	26mm L x 10mm W x 9mm H; 5° Calix-PLIF, PC
M697X0340389PCSTR1	26mm L x 10mm W x 8mm H; 5° Calix-PLIF, PC
M697X0340388PCSTR1	26mm L x 10mm W x 7mm H; 5° Calix-PLIF, PC
M697X0340387PCSTR1	26mm L x 10mm W x 6mm H; 5° Calix-PLIF, PC
M697X0340290PCSTR1	28mm x 10mm x 16mm Calix-TLIF, PC
M697X0340289PCSTR1	28mm x 10mm x 15mm Calix-TLIF, PC
M697X0340288PCSTR1	28mm x 10mm x 14mm Calix-TLIF, PC
M697X0340287PCSTR1	28mm x 10mm x 13mm Calix-TLIF, PC
M697X0340286PCSTR1	28mm x 10mm x 12mm Calix-TLIF, PC
M697X0340285PCSTR1	28mm x 10mm x 11mm Calix-TLIF, PC
M697X0340284PCSTR1	28mm x 10mm x 10mm Calix-TLIF, PC
M697X0340283PCSTR1	28mm x 10mm x 9mm Calix-TLIF, PC
M697X0340282PCSTR1	28mm x 10mm x 8mm Calix-TLIF, PC
M697X0340281PCSTR1	28mm x 10mm x 7mm Calix-TLIF, PC
M697X0340280PCSTR1	28mm x 10mm x 6mm Calix-TLIF, PC
M697X0340253PCSTR1	26mm L x 10mm W x 16mm H; Calix-PLIF, PC
M697X0340249PCSTR1	26mm L x 10mm W x 15mm H; Calix-PLIF, PC
M697X0340248PCSTR1	26mm L x 10mm W x 13mm H; Calix-PLIF, PC
M697X0340247PCSTR1	26mm L x 10mm W x 11mm H; Calix-PLIF, PC
M697X0340246PCSTR1	26mm L x 10mm W x 9mm H; Calix-PLIF, PC
M697X0340245PCSTR1	26mm L x 10mm W x 7mm H; Calix-PLIF, PC
M697X0340244PCSTR1	26mm L x 10mm W x 14mm H; Calix-PLIF, PC
M697X0340243PCSTR1	26mm L x 10mm W x 12mm H; Calix-PLIF, PC
M697X0340242PCSTR1	26mm L x 10mm W x 10mm H; Calix-PLIF, PC
M697X0340241PCSTR1	26mm L x 10mm W x 8mm H; Calix-PLIF, PC
M697X0340240PCSTR1	26mm L x 10mm W x 6mm H; Calix-PLIF, PC
M697X0340181PCSTR1	22mm L x 10mm W x 16mm H; Calix-PLIF, PC
M697X0340180PCSTR1	22mm L x 10mm W x 15mm H; Calix-PLIF, PC
M697X0340179PCSTR1	22mm L x 10mm W x 14mm H; Calix-PLIF, PC
M697X0340178PCSTR1	22mm L x 10mm W x 13mm H; Calix-PLIF, PC
M697X0340177PCSTR1	22mm L x 10mm W x 12mm H; Calix-PLIF, PC
M697X0340176PCSTR1	22mm L x 10mm W x 11mm H; Calix-PLIF, PC
M697X0340175PCSTR1	22mm L x 10mm W x 10mm H; Calix-PLIF, PC
M697X0340174PCSTR1	22mm L x 10mm W x 9mm H; Calix-PLIF, PC
M697X0340173PCSTR1	22mm L x 10mm W x 8mm H; Calix-PLIF, PC
M697X0340172PCSTR1	22mm L x 10mm W x 7mm H; Calix-PLIF, PC
M697X0340171PCSTR1	22mm L x 10mm W x 6mm H; Calix-PLIF, PC
M697X03428900	26mm x 10mm x 16mm PLIF RASP ASSY
M697X03428890	26mm x 10mm x 15mm PLIF RASP ASSY
M697X03428880	26mm x 10mm x 14mm PLIF RASP ASSY
M697X03428870	26mm x 10mm x 13mm PLIF RASP ASSY
M697X03428860	26mm x 10mm x 12mm PLIF RASP ASSY
M697X03428850	26mm x 10mm x 11mm PLIF RASP ASSY