FDA.reportPublic FDA data

Calix Spinal Implant System

Primary DI
M697X0340035PC1
Brand
Calix Spinal Implant System
Company
Xtant Medical Holdings, Inc.
Model
X034-0035PC
Device description
32mm TLIF Implant Caddy ASSY, Calix PC
Published
2015-11-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LRPTRAY, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRPTray, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M697X0340035PC0Direct MarkingHIBCC0
M697X0340035PC1PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Polymeric spinal interbody fusion cageA device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(937)847-8400orders@x-spine.com

Regulatory Flags#

DUNS number
081224143
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M697X07900081Silex Sacroiliac Joint Fusion SystemX079-00082026-07-08
M697X07900671Silex Sacroiliac Joint Fusion SystemX079-00672026-07-08
M697X07901121Silex Sacroiliac Joint Fusion SystemX079-01122026-07-08
M697X07901151Silex Sacroiliac Joint Fusion SystemX079-01152026-07-08
00849777014052Union DBM, 1cc11-0001-0012026-06-24
00849777014069Union DBM, 2.5cc11-0001-0022026-06-24
00849777014076Union DBM, 5cc11-0001-0052026-06-24
00849777014083Union DBM, 10cc11-0001-0102026-06-24
00810076560007BiomaXBMX-00012021-11-02
00810076560380BiomaXBMX-00022021-11-02
00810076560649BiomaXBMX-00052021-11-02
00810076560656BiomaXBMX-00102021-11-02
00810076560663BiomaXBMX-01012021-11-02
00810076560670BiomaXBMX-01022021-11-02
00810076560687BiomaXBMX-01052021-11-02
00810076560694BiomaXBMX-01102021-11-02
00840311263882Streamline OCT20-MODHANDLE20-MODHANDLE2026-06-04
00840311244874Streamline MIS Spinal Fixation System04-55-PR-10004-55-PR-1002026-06-03
00840311244881Streamline MIS Spinal Fixation System04-55-PR-11004-55-PR-1102026-06-03
00840311244904Streamline MIS Spinal Fixation System04-55-PR-13004-55-PR-1302026-06-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03661219527046DELACROIX-CHEVALIERLANDANGERLRP2026-07-12
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10198956499195CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-09
10198956505513CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-09
10198956507180CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-09
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10198956518902CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-09
10198956524934CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-09
10198956524965CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-09
10198956528772CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-09
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10198956529137CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-09
10198956531888CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-09
10198956532519CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-09
10198956532526CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-09
10198956532892CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-09
10198956380615CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-06
10198956477384CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-06
10198956497887CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-06
10198956529175CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-06
10198956529243CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-06
10198956529304CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-06
00190446917861Arsenal FootTrilliant Surgical, LLCLRP2026-06-25
00190446917878Arsenal FootTrilliant Surgical, LLCLRP2026-06-25
00190446934417Arsenal FootTrilliant Surgical, LLCLRP2026-06-25
00190446934424Arsenal FootTrilliant Surgical, LLCLRP2026-06-25
00190446934431Arsenal FootTrilliant Surgical, LLCLRP2026-06-25
00190446934448Arsenal FootTrilliant Surgical, LLCLRP2026-06-25