DBM Putty Plus 2.5cc - Syringe

GUDID 00849777012287

ONE (1) PACKAGE - CONTAINING 2.5cc

Xtant Medical Holdings, Inc.

Bone matrix implant, human-derived
Primary Device ID00849777012287
NIH Device Record Key629c6fe0-e7a1-422a-95e9-5fac37833f23
Commercial Distribution StatusIn Commercial Distribution
Brand NameDBM Putty Plus 2.5cc - Syringe
Version Model NumberMMS3425
Company DUNS081224143
Company NameXtant Medical Holdings, Inc.
Device Count1
DM Exempttrue
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
Phone+1(888)886-9354
EmailCS@xtantmedical.com
Phone+1(888)886-9354
EmailCS@xtantmedical.com
Phone+1(888)886-9354
EmailCS@xtantmedical.com
Phone+1(888)886-9354
EmailCS@xtantmedical.com
Phone+1(888)886-9354
EmailCS@xtantmedical.com
Phone+1(888)886-9354
EmailCS@xtantmedical.com
Phone+1(888)886-9354
EmailCS@xtantmedical.com
Phone+1(888)886-9354
EmailCS@xtantmedical.com
Phone+1(888)886-9354
EmailCS@xtantmedical.com
Phone+1(888)886-9354
EmailCS@xtantmedical.com
Phone+1(888)886-9354
EmailCS@xtantmedical.com
Phone+1(888)886-9354
EmailCS@xtantmedical.com
Phone+1(888)886-9354
EmailCS@xtantmedical.com
Phone+1(888)886-9354
EmailCS@xtantmedical.com
Phone+1(888)886-9354
EmailCS@xtantmedical.com
Phone+1(888)886-9354
EmailCS@xtantmedical.com
Phone+1(888)886-9354
EmailCS@xtantmedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100849777012287 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MBPFiller, Bone Void, Osteoinduction (W/O Human Growth Factor)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-03-06
Device Publish Date2023-02-24

Devices Manufactured by Xtant Medical Holdings, Inc.

M697T09402001 - Atrix-C Cervical Allograft Spacer2024-11-25 Cortical Inserter Tip
M697X09400071 - Atrix-C Cervical Allograft Spacer2024-11-25 SOFT CARRY CASE II, ATRIX-C SPACERS
M697X09400231 - Atrix-C Cervical Allograft Spacer2024-11-25 ATRIX-C CORTICAL/CANCELLOUS IMPLANT SOFT CARRY CASE
00840311207435 - Cortera Spinal Fixation System2024-10-17 Rod, Ti, Prebent, 6.0x25
00840311207442 - Cortera Spinal Fixation System2024-10-17 Rod, Ti, Prebent, 6.0x30
00840311207459 - Cortera Spinal Fixation System2024-10-17 Rod, Ti, Prebent, 6.0x35
00840311207466 - Cortera Spinal Fixation System2024-10-17 Rod, Ti, Prebent, 6.0x40
00840311207473 - Cortera Spinal Fixation System2024-10-17 Rod, Ti, Prebent, 6.0x45

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.