FDA.reportPublic FDA data

Atrix-C Cervical Allograft Spacer

Primary DI
M697X09400031
Brand
Atrix-C Cervical Allograft Spacer
Company
Xtant Medical Holdings, Inc.
Model
X094-0003
Device description
Sterilization Case I, Atrix-C, Instruments
Published
2016-02-23
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
M697X09400030Direct MarkingHIBCC0
M697X09400031PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Cadaveric-donor bone allograftA bone tissue graft harvested from a cadaveric human donor intended for transplantation to provide body mass and structural/mechanical support. It is typically disinfected and frozen for storage prior to implantation.

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
00840311258635C-Plus PEEK IBF System724-729724-7292026-08-26
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00840311211470Streamline TL Spinal Fixation System724-279724-2792026-07-30
00840311264032Cortera Spinal Fixation System1509-1300401509-1300402026-07-20
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

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