Calix-C Cervical Interbody Spacer

GUDID M697T09400591

Forceps Inserter, 13 x 16

X-SPINE SYSTEMS, INC.

Polymeric spinal interbody fusion cage
Primary Device IDM697T09400591
NIH Device Record Keyf0743f76-ba6e-49dd-8361-34d1193ffd72
Commercial Distribution StatusIn Commercial Distribution
Brand NameCalix-C Cervical Interbody Spacer
Version Model NumberT094-0059
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

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 Identifiers

Device Issuing AgencyDevice ID
HIBCCM697T09400590 [Direct Marking]
HIBCCM697T09400591 [Primary]

FDA Product Code

HWAImpactor

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M697T09400591]

Moist Heat or Steam Sterilization


[M697T09400591]

Moist Heat or Steam Sterilization


[M697T09400591]

Moist Heat or Steam Sterilization


[M697T09400591]

Moist Heat or Steam Sterilization


[M697T09400591]

Moist Heat or Steam Sterilization


[M697T09400591]

Moist Heat or Steam Sterilization


[M697T09400591]

Moist Heat or Steam Sterilization


[M697T09400591]

Moist Heat or Steam Sterilization


[M697T09400591]

Moist Heat or Steam Sterilization


[M697T09400591]

Moist Heat or Steam Sterilization


[M697T09400591]

Moist Heat or Steam Sterilization


[M697T09400591]

Moist Heat or Steam Sterilization


[M697T09400591]

Moist Heat or Steam Sterilization


[M697T09400591]

Moist Heat or Steam Sterilization


[M697T09400591]

Moist Heat or Steam Sterilization


[M697T09400591]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-02-24
Device Publish Date2019-12-17

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

M697T09400601Forceps Inserter, 15 x 18
M697T09400591Forceps Inserter, 13 x 16
M697C00300501Special 13mm x 16mm Lordotic Rasp, 5mm

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