Hero DBM Putty, 1.0cc

GUDID 00849777012911

Hero DBM Putty, 1.0cc

Xtant Medical Holdings, Inc.

Bone matrix implant, human-derived
Primary Device ID00849777012911
NIH Device Record Key8cfa20a9-f718-410b-acc7-0a6fd367353b
Commercial Distribution StatusIn Commercial Distribution
Brand NameHero DBM Putty, 1.0cc
Version Model Number01001-001
Company DUNS081224143
Company NameXtant Medical Holdings, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Producttrue
Device Kitfalse
Device Combination Producttrue
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numbertrue
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com
Phone1-888-886-9354
EmailCS@xtantmedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100849777012911 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQVFiller, Bone Void, Calcium Compound

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-09-25
Device Publish Date2024-09-17

Devices Manufactured by Xtant Medical Holdings, Inc.

M697T08500191 - Xspan Laminoplasty Fixation System2025-01-28 PLATE CUTTER, 9INCH
M697T08500250 - Xspan Laminoplasty Fixation System2025-01-28 Lamina Elevator
M697T08500300 - Xspan Laminoplasty Fixation System2025-01-28 ASSEMBLY, DRILL GUIDE
M697T0850041060 - Xspan Laminoplasty Fixation System2025-01-28 PLATE, SIZING TRIAL, INLINE, 6mm
M697T0850041080 - Xspan Laminoplasty Fixation System2025-01-28 PLATE, SIZING TRIAL, INLINE, 8mm
M697T0850041100 - Xspan Laminoplasty Fixation System2025-01-28 PLATE, SIZING TRIAL, INLINE, 10mm
M697T0850041120 - Xspan Laminoplasty Fixation System2025-01-28 PLATE, SIZING TRIAL, INLINE, 12mm
M697T0850042060 - Xspan Laminoplasty Fixation System2025-01-28 PLATE, SIZING TRIAL, SIDE-BY-SIDE, 6mm

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.