Inion GTR™ TCK-2013

GUDID 06438408005572

Tacks (4 x)

Inion Oy

Spinal bone screw, bioabsorbable
Primary Device ID06438408005572
NIH Device Record Key6dfe74ec-e267-4314-bf89-da9bc5e1968a
Commercial Distribution StatusIn Commercial Distribution
Brand NameInion GTR™
Version Model Number1
Catalog NumberTCK-2013
Company DUNS367994657
Company NameInion Oy
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106438408005572 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NPKBarrier, synthetic, intraoral

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-12-27
Device Publish Date2023-12-19

On-Brand Devices [Inion GTR™]

M224TCK20139Tacks (4 x)
M224TCK20119Tacks, drill bit and tack appl.
M224TCK20029Tacks and drill bit
M224MBR20009Membrane 30x40 mm
06438408010750Membrane 30x40 mm
06438408007279Tacks and drill bit
06438408005572Tacks (4 x)
06438408005565Tacks, drill bit and tack appl.

Trademark Results [Inion GTR]

Mark Image

Registration | Serial
Company
Trademark
Application Date
INION GTR
INION GTR
78529640 3195690 Dead/Cancelled
INION OY
2004-12-09

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