DBM Putty Plus 5.0cc - Jar

GUDID 00849777012249

ONE (1) PACKAGE - CONTAINING 5.0cc

Xtant Medical Holdings, Inc.

Bone matrix implant, human-derived
Primary Device ID00849777012249
NIH Device Record Key92e294c0-874c-497f-bfce-76b5f88e6bc5
Commercial Distribution StatusIn Commercial Distribution
Brand NameDBM Putty Plus 5.0cc - Jar
Version Model NumberMM3450
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

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
GS100849777012249 [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 StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2024-09-23
Device Publish Date2023-01-11

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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

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