VIA DBM Plus, 5cc

GUDID 00849777011679

ONE (1) PACKAGE - CONTAINING 5.0cc

Xtant Medical Holdings, Inc.

Bone matrix implant, human-derived
Primary Device ID00849777011679
NIH Device Record Key44280525-1a34-46f1-be53-0618ae4bee3e
Commercial Distribution StatusIn Commercial Distribution
Brand NameVIA DBM Plus, 5cc
Version Model NumberVX-EP5
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100849777011679 [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 Date2021-07-01
Device Publish Date2021-06-23

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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
00840311207480 - Cortera Spinal Fixation System2024-10-17 Rod, Ti, Prebent, 6.0x50
00840311207497 - Cortera Spinal Fixation System2024-10-17 Rod, Ti, Prebent, 6.0x55
00840311207503 - Cortera Spinal Fixation System2024-10-17 Rod, Ti, Prebent, 6.0x60

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