PxHA® HA1214320

GUDID M711HA12143200

HA PEEK, Tantalum

Innovasis, Inc.

Polymeric spinal fusion cage, sterile Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage
Primary Device IDM711HA12143200
NIH Device Record Key4be2401c-5e6b-4c0d-9209-2dd1a38ead3d
Commercial Distribution StatusIn Commercial Distribution
Brand NamePxHA®
Version Model NumberHA1214320
Catalog NumberHA1214320
Company DUNS156567492
Company NameInnovasis, Inc.
Device Count1
DM Exempttrue
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

Customer Support Contacts

Phone801-261-2236
Emailinfo@innovasis.com
Phone801-261-2236
Emailinfo@innovasis.com
Phone801-261-2236
Emailinfo@innovasis.com
Phone801-261-2236
Emailinfo@innovasis.com
Phone801-261-2236
Emailinfo@innovasis.com
Phone801-261-2236
Emailinfo@innovasis.com
Phone801-261-2236
Emailinfo@innovasis.com
Phone801-261-2236
Emailinfo@innovasis.com
Phone801-261-2236
Emailinfo@innovasis.com
Phone801-261-2236
Emailinfo@innovasis.com
Phone801-261-2236
Emailinfo@innovasis.com
Phone801-261-2236
Emailinfo@innovasis.com
Phone801-261-2236
Emailinfo@innovasis.com
Phone801-261-2236
Emailinfo@innovasis.com
Phone801-261-2236
Emailinfo@innovasis.com
Phone801-261-2236
Emailinfo@innovasis.com
Phone801-261-2236
Emailinfo@innovasis.com
Phone801-261-2236
Emailinfo@innovasis.com

Device Dimensions

Angle0 degree
Width12 Millimeter
Height14 Millimeter
Length32 Millimeter
Angle0 degree
Width12 Millimeter
Height14 Millimeter
Length32 Millimeter
Angle0 degree
Width12 Millimeter
Height14 Millimeter
Length32 Millimeter
Angle0 degree
Width12 Millimeter
Height14 Millimeter
Length32 Millimeter
Angle0 degree
Width12 Millimeter
Height14 Millimeter
Length32 Millimeter
Angle0 degree
Width12 Millimeter
Height14 Millimeter
Length32 Millimeter
Angle0 degree
Width12 Millimeter
Height14 Millimeter
Length32 Millimeter
Angle0 degree
Width12 Millimeter
Height14 Millimeter
Length32 Millimeter
Angle0 degree
Width12 Millimeter
Height14 Millimeter
Length32 Millimeter
Angle0 degree
Width12 Millimeter
Height14 Millimeter
Length32 Millimeter
Angle0 degree
Width12 Millimeter
Height14 Millimeter
Length32 Millimeter
Angle0 degree
Width12 Millimeter
Height14 Millimeter
Length32 Millimeter
Angle0 degree
Width12 Millimeter
Height14 Millimeter
Length32 Millimeter
Angle0 degree
Width12 Millimeter
Height14 Millimeter
Length32 Millimeter
Angle0 degree
Width12 Millimeter
Height14 Millimeter
Length32 Millimeter
Angle0 degree
Width12 Millimeter
Height14 Millimeter
Length32 Millimeter
Angle0 degree
Width12 Millimeter
Height14 Millimeter
Length32 Millimeter
Angle0 degree

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM711HA12143200 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-04-15
Device Publish Date2017-04-17

On-Brand Devices [PxHA®]

M711HA12163000HA PEEK, Tantalum
M711HA12162800HA PEEK, Tantalum
M711HA12153200HA PEEK, Tantalum
M711HA12153000HA PEEK, Tantalum
M711HA12143200HA PEEK, Tantalum
M711HA12143000HA PEEK, Tantalum
M711HA12142800HA PEEK, Tantalum
M711HA12133200HA PEEK, Tantalum
M711HA12133000HA PEEK, Tantalum
M711HA12132800HA PEEK, Tantalum
M711HA12123200HA PEEK, Tantalum
M711HA12123000HA PEEK, Tantalum
M711HA12122800HA PEEK, Tantalum
M711HA12113200HA PEEK, Tantalum
M711HA12113000HA PEEK, Tantalum
M711HA12112800HA PEEK, Tantalum
M711HA12103200HA PEEK, Tantalum
M711HA12103000HA PEEK, Tantalum
M711HA12102800HA PEEK, Tantalum
M711HA12093200HA PEEK, Tantalum
M711HA12093000HA PEEK, Tantalum
M711HA12092800HA PEEK, Tantalum
M711HA12082800HA PEEK, Tantalum
M711HA10162550HA PEEK, Tantalum
M711HA10162500HA PEEK, Tantalum
M711HA10162250HA PEEK, Tantalum
M711HA10162200HA PEEK, Tantalum
M711HA10153200HA PEEK, Tantalum
M711HA10152800HA PEEK, Tantalum
M711HA10152550HA PEEK, Tantalum
M711HA10152500HA PEEK, Tantalum
M711HA10152250HA PEEK, Tantalum
M711HA10152200HA PEEK, Tantalum
M711HA10143200HA PEEK, Tantalum
M711HA10142800HA PEEK, Tantalum
M711HA10142550HA PEEK, Tantalum
M711HA10142500HA PEEK, Tantalum
M711HA10142250HA PEEK, Tantalum
M711HA10142200HA PEEK, Tantalum
M711HA10133200HA PEEK, Tantalum
M711HA10132800HA PEEK, Tantalum
M711HA10132550HA PEEK, Tantalum
M711HA10132500HA PEEK, Tantalum
M711HA10132250HA PEEK, Tantalum
M711HA10132200HA PEEK, Tantalum
M711HA10123200HA PEEK, Tantalum
M711HA10122800HA PEEK, Tantalum
M711HA10122550HA PEEK, Tantalum
M711HA10122500HA PEEK, Tantalum
M711HA10122250HA PEEK, Tantalum

Trademark Results [PxHA]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PXHA
PXHA
88046148 not registered Live/Pending
Innovasis, Inc.
2018-07-20

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.