FDA.reportPublic FDA data

Inion GTR™

Primary DI
M224TCK20139
Brand
Inion GTR™
Company
Inion Oy
Model
1
Catalog number
TCK-2013
Device description
Tacks (4 x)
Published
2017-02-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NPKBarrier, synthetic, intraoral

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NPKBarrier, Synthetic, IntraoralDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K033074000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K033074000INION GTR BIODEGRADABLE MEMBRANE SYSTEMInion , Ltd.2004-03-31NPK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M224TCK20139PrimaryHIBCC0
06438408005572SecondaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06438408005572064384080055726438408005572

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone screw, bioabsorbableA small, sterile, threaded rod with a slotted head intended to be used for internal spinal fixation by being screwed into the spine to hold plates, or other stabilization device, to bone; it is made of a material that is chemically degraded and typically absorbed via natural body processes (e.g., degradable polymers). The device is available in various types, including pedicle and transfacet, and is typically used in spinal discectomy and fusion procedures as a means to maintain the relative position of bone allografts or autografts.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
367994657
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06438408012587Inion® Universal instruments2INS-90912026-05-11
06438408012037Inion Hexalon instrument2INS-92002026-05-06
06438408002397Inion Hexalon™ ACL/PCL Screw1ACL-41132022-08-26
06438408002403Inion Hexalon™ ACL/PCL Screw1ACL-41142022-08-26
06438408002410Inion Hexalon™ ACL/PCL Screw1ACL-41152022-08-26
06438408002427Inion Hexalon™ ACL/PCL Screw1ACL-41012022-08-26
06438408002434Inion Hexalon™ ACL/PCL Screw1ACL-41022022-08-26
06438408002441Inion Hexalon™ ACL/PCL Screw1ACL-41032022-08-26
06438408002458Inion Hexalon™ ACL/PCL Screw1ACL-41042022-08-26
06438408002465Inion Hexalon™ ACL/PCL Screw1ACL-41052022-08-26
06438408002472Inion Hexalon™ ACL/PCL Screw1ACL-41062022-08-26
06438408002489Inion Hexalon™ ACL/PCL Screw1ACL-41072022-08-26
06438408002496Inion Hexalon™ ACL/PCL Screw1ACL-41082022-08-26
06438408002502Inion Hexalon™ ACL/PCL Screw1ACL-41092022-08-26
06438408002519Inion Hexalon™ ACL/PCL Screw1ACL-41122022-08-26
06438408012181Inion S-1™1SPN-50042023-12-19
06438408012198Inion S-1™1SPN-50052023-12-19
06438408012204Inion S-1™1SPN-50062023-12-19
06438408012211Inion S-1™1SPN-50072023-12-19
06438408012099Inion CPS™ instrumentation1INS-92752026-01-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00841336100213Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCNPK2025-11-11
08800016105865InnoGenic™ Non-resorbable Membrane-InnoGenic™ Wifi-MeshCowellmedi Co.,LtdNPK2025-10-14
08800039006682TBS PTFE membranePURGO BIOLOGICS Inc.NPK2025-07-24
D767C0609010Perforated Cytoflex Ti-enforcedUNICARE BIOMEDICAL INC.NPK2024-07-12
D767C0613010Perforated Cytoflex Ti-enforcedUNICARE BIOMEDICAL INC.NPK2024-07-12
D767C0617010Perforated Cytoflex Ti-enforcedUNICARE BIOMEDICAL INC.NPK2024-07-12
D767C0635010Perforated Cytoflex Ti-enforcedUNICARE BIOMEDICAL INC.NPK2024-07-12
D767C0639010Perforated Cytoflex Ti-enforcedUNICARE BIOMEDICAL INC.NPK2024-07-12
D767C0641010Perforated Cytoflex Ti-enforcedUNICARE BIOMEDICAL INC.NPK2024-07-12
08800016107135InnoGenic™ Non-resorbable Membrane-InnoGenic™ Wifi-MeshCowellmedi Co.,LtdNPK2024-05-24
08800016107142InnoGenic™ Non-resorbable Membrane-InnoGenic™ Wifi-MeshCowellmedi Co.,LtdNPK2024-05-24
08800016107159InnoGenic™ Non-resorbable Membrane-InnoGenic™ Wifi-MeshCowellmedi Co.,LtdNPK2024-05-24
08800016107166InnoGenic™ Non-resorbable Membrane-InnoGenic™ Wifi-MeshCowellmedi Co.,LtdNPK2024-05-24
08800016107173InnoGenic™ Non-resorbable Membrane-InnoGenic™ Wifi-MeshCowellmedi Co.,LtdNPK2024-05-24
08800016107180InnoGenic™ Non-resorbable Membrane-InnoGenic™ Wifi-MeshCowellmedi Co.,LtdNPK2024-05-24
08800016107241InnoGenic™ Non-resorbable Membrane-InnoGenic™ Wifi-MeshCowellmedi Co.,LtdNPK2024-05-24
08800016107258InnoGenic™ Non-resorbable Membrane-InnoGenic™ Wifi-MeshCowellmedi Co.,LtdNPK2024-05-24
08800016108002InnoGenic™ Non-resorbable Membrane-InnoGenic™ Wifi-MeshCowellmedi Co.,LtdNPK2024-05-24
08800016144963InnoGenic™ Non-resorbable Membrane-InnoGenic™ Wifi-MeshCowellmedi Co.,LtdNPK2024-05-24
08800016144987InnoGenic™ Non-resorbable Membrane-InnoGenic™ Wifi-MeshCowellmedi Co.,LtdNPK2024-05-24
08800016144994InnoGenic™ Non-resorbable Membrane-InnoGenic™ Wifi-MeshCowellmedi Co.,LtdNPK2024-05-24
08809471726370InnoGenic™ Non-resorbable Membrane-InnoGenic™ PTFE-MeshCowellmedi Co.,LtdNPK2024-05-24
08809471726387InnoGenic™ Non-resorbable Membrane-InnoGenic™ PTFE-MeshCowellmedi Co.,LtdNPK2024-05-24
08809471726394InnoGenic™ Non-resorbable Membrane-InnoGenic™ PTFE-MeshCowellmedi Co.,LtdNPK2024-05-24
08809471726400InnoGenic™ Non-resorbable Membrane-InnoGenic™ PTFE-MeshCowellmedi Co.,LtdNPK2024-05-24
D767C0501010Cytoflex Ti-enforcedUNICARE BIOMEDICAL INC.NPK2024-01-10
D767C0503010Cytoflex Ti-enforcedUNICARE BIOMEDICAL INC.NPK2024-01-10
D767C0505010Cytoflex Ti-enforcedUNICARE BIOMEDICAL INC.NPK2024-01-10
D767C0507010Cytoflex Ti-enforcedUNICARE BIOMEDICAL INC.NPK2024-01-10