VIA DBM Putty, 5cc

GUDID 00849777011709

ONE (1) PACKAGE - CONTAINING 5.0cc

Xtant Medical Holdings, Inc.

Bone matrix implant, human-derived Bone matrix implant, human-derived Bone matrix implant, human-derived Bone matrix implant, human-derived Bone matrix implant, human-derived Bone matrix implant, human-derived Bone matrix implant, human-derived Bone matrix implant, human-derived Bone matrix implant, human-derived Bone matrix implant, human-derived Bone matrix implant, human-derived Bone matrix implant, human-derived Bone matrix implant, human-derived Bone matrix implant, human-derived Bone matrix implant, human-derived Bone matrix implant, human-derived
Primary Device ID00849777011709
NIH Device Record Key8429c50b-d72d-4a78-b7c9-4e15b257d77b
Commercial Distribution StatusIn Commercial Distribution
Brand NameVIA DBM Putty, 5cc
Version Model NumberDBM005
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
GS100849777011709 [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

Devices Manufactured by Xtant Medical Holdings, Inc.

00840311247912 - Cervalign2024-04-15 Cervalign, Rigid Screw Inserter, Sleeve
M697C02210000 - Fortex Pedicle Screw System2023-05-18 Special Adjustment Screwdriver Assembly Non-cannulated
M697C02200191 - Fortex Pedicle Screw System2023-04-06 4.75mm Special Single Lead Tap
M697C02200201 - Fortex Pedicle Screw System2023-04-06 5.5mm Special Single Lead Tap
M697C02200211 - Fortex Pedicle Screw System2023-04-06 6.5mm Special Single Lead Tap
M697C02200221 - Fortex Pedicle Screw System2023-04-06 7.5mm Special Single Lead Tap
M697C02200231 - Fortex Pedicle Screw System2023-04-06 8.25mm Special Single Lead Tap
M697C03410001 - Calix Lumbar Spinal Implant System2023-03-07 ASSEMBLY, SPECIAL INSERTER
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.