Calix-C Cervical Interbody Spacer

GUDID M697C00300540

Special 13mm x 16mm Lordotic Rasp, 9mm

Xtant Medical Holdings, Inc.

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Primary Device IDM697C00300540
NIH Device Record Keyc8eb4948-c518-4395-99bd-21fb03dc7ae3
Commercial Distribution StatusIn Commercial Distribution
Brand NameCalix-C Cervical Interbody Spacer
Version Model NumberC003-0054
Company DUNS081224143
Company NameXtant Medical Holdings, 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

Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com

Device Dimensions

Width16 Millimeter
Length13 Millimeter
Height9 Millimeter
Angle7 degree
Width16 Millimeter
Length13 Millimeter
Height9 Millimeter
Angle7 degree
Width16 Millimeter
Length13 Millimeter
Height9 Millimeter
Angle7 degree
Width16 Millimeter
Length13 Millimeter
Height9 Millimeter
Angle7 degree
Width16 Millimeter
Length13 Millimeter
Height9 Millimeter
Angle7 degree
Width16 Millimeter
Length13 Millimeter
Height9 Millimeter
Angle7 degree
Width16 Millimeter
Length13 Millimeter
Height9 Millimeter
Angle7 degree
Width16 Millimeter
Length13 Millimeter
Height9 Millimeter
Angle7 degree
Width16 Millimeter
Length13 Millimeter
Height9 Millimeter
Angle7 degree
Width16 Millimeter
Length13 Millimeter
Height9 Millimeter
Angle7 degree
Width16 Millimeter
Length13 Millimeter
Height9 Millimeter
Angle7 degree
Width16 Millimeter
Length13 Millimeter
Height9 Millimeter
Angle7 degree
Width16 Millimeter
Length13 Millimeter
Height9 Millimeter
Angle7 degree
Width16 Millimeter
Length13 Millimeter
Height9 Millimeter
Angle7 degree
Width16 Millimeter
Length13 Millimeter
Height9 Millimeter
Angle7 degree
Width16 Millimeter
Length13 Millimeter
Height9 Millimeter
Angle7 degree

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM697C00300540 [Direct Marking]
HIBCCM697C00300541 [Primary]

FDA Product Code

HTRRasp

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M697C00300540]

Moist Heat or Steam Sterilization


[M697C00300540]

Moist Heat or Steam Sterilization


[M697C00300540]

Moist Heat or Steam Sterilization


[M697C00300540]

Moist Heat or Steam Sterilization


[M697C00300540]

Moist Heat or Steam Sterilization


[M697C00300540]

Moist Heat or Steam Sterilization


[M697C00300540]

Moist Heat or Steam Sterilization


[M697C00300540]

Moist Heat or Steam Sterilization


[M697C00300540]

Moist Heat or Steam Sterilization


[M697C00300540]

Moist Heat or Steam Sterilization


[M697C00300540]

Moist Heat or Steam Sterilization


[M697C00300540]

Moist Heat or Steam Sterilization


[M697C00300540]

Moist Heat or Steam Sterilization


[M697C00300540]

Moist Heat or Steam Sterilization


[M697C00300540]

Moist Heat or Steam Sterilization


[M697C00300540]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-06-30
Device Publish Date2021-06-22

On-Brand Devices [Calix-C Cervical Interbody Spacer]

M697C00300570Special 13mm x 16mm Lordotic Rasp, 12mm
M697C00300560Special 13mm x 16mm Lordotic Rasp, 11mm
M697C00300550Special 13mm x 16mm Lordotic Rasp, 10mm
M697C00300540Special 13mm x 16mm Lordotic Rasp, 9mm
M697C00300530Special 13mm x 16mm Lordotic Rasp, 8mm
M697C00300520Special 13mm x 16mm Lordotic Rasp, 7mm
M697C00300510Special 13mm x 16mm Lordotic Rasp, 6mm
M697C00300590SPECIAL LORDOTIC RASP, 11mm x 14mm x 6mm
M697C00300580SPECIAL LORDOTIC RASP, 11mm x 14mm x 5mm

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