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H-graft Interspinous Allograft

FDA UDI

Class I (US FDA UDI)

by Xtant Medical Holdings, Inc.

Identity

Trade Name
H-graft Interspinous Allograft FDA UDI
Generic Name
Cadaveric-donor bone allograft FDA UDI
Device Name
Sm. Distraction Screw Sleeve FDA UDI
Model / Reference
C078-0023 FDA UDI
Description
Sm. Distraction Screw Sleeve FDA UDI

Identifiers

Primary DI / UDI-DI
M697C07800231 FDA UDI
FDA Product Code
HWB FDA UDI
GMDN Term
Cadaveric-donor bone allograft FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4540 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Cadaveric-donor bone allograft

H-graft Interspinous Allograft by Xtant Medical Holdings, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cadaveric-donor bone allograft.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Xtant Medical Holdings, Inc.

Sources (1)

  • FDA UDI fce2005b-c609-4750-9425-ff6e26b6729f 34 fields · synced May 30, 2026