FDA.reportPublic FDA data

H-graft Interspinous Allograft

Primary DI
M697X07800881
Brand
H-graft Interspinous Allograft
Company
Xtant Medical Holdings, Inc.
Model
X078-0088
Device description
18mm Distraction Screw
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
HWBEXTRACTOR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWBExtractorOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M697X07800881PrimaryHIBCC0

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length18Millimeter

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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M697X07900671Silex Sacroiliac Joint Fusion SystemX079-00672026-07-08
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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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