Calix Lumbar Spinal Implant System

GUDID M697C03410001

ASSEMBLY, SPECIAL INSERTER

Xtant Medical Holdings, Inc.

Polymeric spinal interbody fusion cage
Primary Device IDM697C03410001
NIH Device Record Key1cbd9d1b-9137-4a86-b643-bb7f5992de7f
Commercial Distribution StatusIn Commercial Distribution
Brand NameCalix Lumbar Spinal Implant System
Version Model NumberC034-1000
Company DUNS081224143
Company NameXtant Medical Holdings, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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
Phone1-888-886-9354
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
Phone+1(888)886-9354
EmailCS@xtantmedical.com
Phone+1(888)886-9354
EmailCS@xtantmedical.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM697C03410001 [Primary]

FDA Product Code

HWAImpactor

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M697C03410001]

Moist Heat or Steam Sterilization

[M697C03410001]

Moist Heat or Steam Sterilization

[M697C03410001]

Moist Heat or Steam Sterilization

[M697C03410001]

Moist Heat or Steam Sterilization

[M697C03410001]

Moist Heat or Steam Sterilization

[M697C03410001]

Moist Heat or Steam Sterilization

[M697C03410001]

Moist Heat or Steam Sterilization

[M697C03410001]

Moist Heat or Steam Sterilization

[M697C03410001]

Moist Heat or Steam Sterilization

[M697C03410001]

Moist Heat or Steam Sterilization

[M697C03410001]

Moist Heat or Steam Sterilization

[M697C03410001]

Moist Heat or Steam Sterilization

[M697C03410001]

Moist Heat or Steam Sterilization

[M697C03410001]

Moist Heat or Steam Sterilization

[M697C03410001]

Moist Heat or Steam Sterilization

[M697C03410001]

Moist Heat or Steam Sterilization

[M697C03410001]

Moist Heat or Steam Sterilization

[M697C03410001]

Moist Heat or Steam Sterilization

[M697C03410001]

Moist Heat or Steam Sterilization

[M697C03410001]

Moist Heat or Steam Sterilization

[M697C03410001]

Moist Heat or Steam Sterilization

[M697C03410001]

Moist Heat or Steam Sterilization

[M697C03410001]

Moist Heat or Steam Sterilization

[M697C03410001]

Moist Heat or Steam Sterilization

[M697C03410001]

Moist Heat or Steam Sterilization

[M697C03410001]

Moist Heat or Steam Sterilization

[M697C03410001]

Moist Heat or Steam Sterilization

[M697C03410001]

Moist Heat or Steam Sterilization

[M697C03410001]

Moist Heat or Steam Sterilization

[M697C03410001]

Moist Heat or Steam Sterilization

[M697C03410001]

Moist Heat or Steam Sterilization

[M697C03410001]

Moist Heat or Steam Sterilization

[M697C03410001]

Moist Heat or Steam Sterilization

[M697C03410001]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-03-07
Device Publish Date2023-02-27

Devices Manufactured by Xtant Medical Holdings, Inc.

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00840311262670 - Cortera Spinal Fixation System2025-12-30 Caddy, Set Screw, 5.5-6.0
00840311262687 - Cortera Spinal Fixation System2025-12-30 Lid, Set Screw, 5.5-6.0
00840311262663 - Streamline TL Spinal Fixation System2025-12-25 Streamline TL, 8.5mm Long Screw Caddy
00840311262632 - Fusion™ Posterior Instrument Set2025-12-19 VBR, Graft Funnel
00840311244713 - Cortera Spinal Fixation System2025-12-18 NAV Instruments Set, ASM
00840311244720 - Cortera Spinal Fixation System2025-12-18 Case, Full, NAV INS
00840311244737 - Cortera Spinal Fixation System2025-12-18 Tray, Full, NAV INS, Level 1
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