PxHA­® HA1215280

GUDID M711HA12152800

HA PEEK, Tantalum

Innovasis, Inc.

Polymeric spinal fusion cage, sterile
Primary Device IDM711HA12152800
NIH Device Record Keyce15731c-1bde-420b-b601-10f9dbe09603
Commercial Distribution StatusIn Commercial Distribution
Brand NamePxHA­®
Version Model NumberHA1215280
Catalog NumberHA1215280
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

Device Dimensions

Angle0 degree
Width12 Millimeter
Height15 Millimeter
Length28 Millimeter
Angle0 degree
Width12 Millimeter
Height15 Millimeter
Length28 Millimeter
Angle0 degree
Width12 Millimeter
Height15 Millimeter
Length28 Millimeter
Angle0 degree
Width12 Millimeter
Height15 Millimeter
Length28 Millimeter
Angle0 degree
Width12 Millimeter
Height15 Millimeter
Length28 Millimeter
Angle0 degree
Width12 Millimeter
Height15 Millimeter
Length28 Millimeter
Angle0 degree
Width12 Millimeter
Height15 Millimeter
Length28 Millimeter
Angle0 degree
Width12 Millimeter
Height15 Millimeter
Length28 Millimeter
Angle0 degree
Width12 Millimeter
Height15 Millimeter
Length28 Millimeter
Angle0 degree
Width12 Millimeter
Height15 Millimeter
Length28 Millimeter
Angle0 degree
Width12 Millimeter
Height15 Millimeter
Length28 Millimeter
Angle0 degree
Width12 Millimeter
Height15 Millimeter
Length28 Millimeter
Angle0 degree
Width12 Millimeter
Height15 Millimeter
Length28 Millimeter
Angle0 degree
Width12 Millimeter
Height15 Millimeter
Length28 Millimeter
Angle0 degree

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM711HA12152800 [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

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M711LS758120 - HAtetracell™-C2024-12-09 Trial, 13L x 15W x 11-12H x 12°, SST
M711LS758180 - HAtetracell™-C2024-12-09 Trial, 14L x 17W x 11-12H x 12°, SST
M711LS758190 - HAtetracell™-C2024-12-09 Trial, 15L x 17W x 7-8H x 12°, SST
M711LS758200 - HAtetracell™-C2024-12-09 Trial, 15L x 17W x 9-10H x 12°, SST
M711LS758220 - HAtetracell™-C2024-12-09 Trial, 16L x 18W x 7-8H x 12°, SST
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