FDA.reportPublic FDA data

H-graft Interspinous Allograft

Primary DI
M697X07801001
Brand
H-graft Interspinous Allograft
Company
Xtant Medical Holdings, Inc.
Model
X078-0100
Device description
Trial Shaft
Published
2015-08-28
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
HWTTEMPLATE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWTTemplateOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M697X07801001PrimaryHIBCC0

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
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

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M697X07382590DL1Xpress Minimally Invasive Pedicle Screw SystemX073-82590-DL2026-10-14
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00849777014144Vesuvius Flowable DBM, 1cc4104-K5010DP2026-09-14
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