FDA.reportPublic FDA data

Atrix-C Cervical Allograft Spacer

Primary DI
M697T09402000
Brand
Atrix-C Cervical Allograft Spacer
Company
Xtant Medical Holdings, Inc.
Model
T073-0200
Device description
Cortical Inserter Tip
Published
2016-02-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWAIMPACTOR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWAImpactorOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M697T09402000Direct MarkingHIBCC0
M697T07302001PrimaryHIBCC0
M697T09402001PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Cadaveric-donor bone allograftBone intended for transplantation that is harvested from a cadaveric human donor genetically different from the human recipient, typically cadaver bone from a bone bank where donor bone is typically disinfected and stored after stabilization by rapid freezing and dehydration under vacuum conditions (i.e., lyophilization). The bone is permanently implanted during plastic (reconstructive/augmentation) surgeries to provide body mass and structural/mechanical support.

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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M697X07300251Xpress Minimally Invasive Pedicle Screw SystemX073-00252026-10-14
M697X07300261Xpress Minimally Invasive Pedicle Screw SystemX073-00262026-10-14
M697X07300271Xpress Minimally Invasive Pedicle Screw SystemX073-00272026-10-14
M697X07300291Xpress Minimally Invasive Pedicle Screw SystemX073-00292026-10-14
M697X073825100DL1Xpress Minimally Invasive Pedicle Screw SystemX073-825100-DL2026-10-14
M697X07382560DL1Xpress Minimally Invasive Pedicle Screw SystemX073-82560-DL2026-10-14
M697X07382565DL1Xpress Minimally Invasive Pedicle Screw SystemX073-82565-DL2026-10-14
M697X07382570DL1Xpress Minimally Invasive Pedicle Screw SystemX073-82570-DL2026-10-14
M697X07382575DL1Xpress Minimally Invasive Pedicle Screw SystemX073-82575-DL2026-10-14
M697X07382580DL1Xpress Minimally Invasive Pedicle Screw SystemX073-82580-DL2026-10-14
M697X07382585DL1Xpress Minimally Invasive Pedicle Screw SystemX073-82585-DL2026-10-14
M697X07382590DL1Xpress Minimally Invasive Pedicle Screw SystemX073-82590-DL2026-10-14
M697X07382595DL1Xpress Minimally Invasive Pedicle Screw SystemX073-82595-DL2026-10-14
00849777014144Vesuvius Flowable DBM, 1cc4104-K5010DP2026-09-14
00849777014151Vesuvius Flowable DBM, 2.5cc4104-K5025DP2026-09-14
00849777014168Vesuvius Flowable DBM, 5cc4104-K5050DP2026-09-14
00849777014175Vesuvius Flowable DBM, 10cc4104-K5100DP2026-09-14

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04719886914825U-Motion IIUNITED ORTHOPEDIC CORP.HWA2026-10-15
04719886914832U-Motion IIUNITED ORTHOPEDIC CORP.HWA2026-10-15
04719886914849U-Motion IIUNITED ORTHOPEDIC CORP.HWA2026-10-15
04719886914856U-Motion IIUNITED ORTHOPEDIC CORP.HWA2026-10-15
04719886914863U-Motion IIUNITED ORTHOPEDIC CORP.HWA2026-10-15
04719886915471Momentum Acetabular Cup SystemUNITED ORTHOPEDIC CORP.HWA2026-10-15
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