DBM Putty 5.0cc

GUDID 00849777012126

ONE (1) PACKAGE - CONTAINING 5.0cc (jar)

Xtant Medical Holdings, Inc.

Bone matrix implant, human-derived
Primary Device ID00849777012126
NIH Device Record Key5d5d7499-144c-4d26-9597-e573b46b3d00
Commercial Distribution StatusIn Commercial Distribution
Brand NameDBM Putty 5.0cc
Version Model NumberLD-600-050-M
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
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
GS100849777012126 [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 Date2022-04-14
Device Publish Date2022-04-06

Devices Manufactured by Xtant Medical Holdings, Inc.

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00840311253494 - Cortera Spinal Fixation System2025-08-29 CONNECTOR, R2R, OPEN-OPEN, 5.5-6.0, 11mm
00840311253500 - Cortera Spinal Fixation System2025-08-29 CONNECTOR, R2R, OPEN-OPEN, 5.5-6.0, 15mm
00840311253517 - Cortera Spinal Fixation System2025-08-29 CONNECTOR, R2R, OPEN-OPEN, 5.5-6.0, 19mm
00840311253524 - Cortera Spinal Fixation System2025-08-29 CONNECTOR, R2R, OPEN-SIDE, 5.5-6.0, 11mm
00840311253531 - Cortera Spinal Fixation System2025-08-29 CONNECTOR, R2R, OPEN-SIDE, 5.5-6.0, 15mm
00840311253548 - Cortera Spinal Fixation System2025-08-29 CONNECTOR, R2R, OPEN-SIDE, 5.5-6.0, 19mm
00840311253555 - Cortera Spinal Fixation System2025-08-29 CONNECTOR, R2R, CLOSED, 4H, 11mm

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