OSTEOMATRIX+ OMP-18

GUDID 00816986020129

OSTEOMATRIX+ is a bone graft substitute comprising biphasic mineral granules suspended in a porous type I collagen matrix. The device is provided sterile and is to be combined with autologous bone marrow aspirate prior to use to facilitate packing into bony defects. The device provides an osteoconductive scaffold that resorbs and guides host bone regeneration during the healing process.

BIOVENTUS LLC

Synthetic bone graft Synthetic bone graft Synthetic bone graft
Primary Device ID00816986020129
NIH Device Record Key93aa83b1-8e1e-4ed5-8833-1b39c23c4ed9
Commercial Distribution StatusIn Commercial Distribution
Brand NameOSTEOMATRIX+
Version Model Number18cc
Catalog NumberOMP-18
Company DUNS078450878
Company NameBIOVENTUS LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100816986020129 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQVFiller, Bone Void, Calcium Compound

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-01-14
Device Publish Date2018-12-13

On-Brand Devices [OSTEOMATRIX+]

00816986020129OSTEOMATRIX+ is a bone graft substitute comprising biphasic mineral granules suspended in a poro
00816986020112OSTEOMATRIX+ is a bone graft substitute comprising biphasic mineral granules suspended in a poro

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