DEVICE: H-graft Interspinous Allograft (M697X07800841)
Device Identifier (DI) Information
H-graft Interspinous Allograft
X078-0084
In Commercial Distribution
Xtant Medical Holdings, Inc.
X078-0084
In Commercial Distribution
Xtant Medical Holdings, Inc.
14mm Distraction Screw
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
47938 | Cadaveric-donor bone allograft |
A 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.
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
HWB | EXTRACTOR |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Length: 14 Millimeter |
Device Record Status
b7423b06-bd57-4b6c-8790-8c3f659d1ed9
June 10, 2022
5
August 28, 2015
June 10, 2022
5
August 28, 2015
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(937)847-8400
orders@x-spine.com
orders@x-spine.com