FDA.reportPublic FDA data

Hexanium® TLIF

Primary DI
03663136032023
Brand
Hexanium® TLIF
Company
SPINEVISION
Model
TL3-A011-14
Device description
Reamer 14
Published
2018-05-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTOReamer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTOReamerOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03663136032023PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03663136032023036631360320233663136032023

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, reusableA collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height14Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+33153332525corp.quality@spinevision.com

Regulatory Flags#

DUNS number
390377518
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03663136009308Hexanium® ACIFAC2-A012-M11L2025-02-20
03663136009315Hexanium® ACIFAC2-A012-M09L2025-02-20
03663136009322Hexanium® ACIFAC2-A012-M07L2025-02-20
03663136009339Hexanium® ACIFAC2-A012-M05L2025-02-20
03663136009346Hexanium® ACIFAC2-A012-S11L2025-02-20
03663136009353Hexanium® ACIFAC2-A012-S09L2025-02-20
03663136009360Hexanium® ACIFAC2-A012-S07L2025-02-20
03663136009384Hexanium® ACIFAC2-A012-L11C2025-02-20
03663136009391Hexanium® ACIFAC2-A012-L09C2025-02-20
03663136009407Hexanium® ACIFAC2-A012-L07C2025-02-20
03663136009414Hexanium® ACIFAC2-A012-L05C2025-02-20
03663136009421Hexanium® ACIFAC2-A012-M11C2025-02-20
03663136009438Hexanium® ACIFAC2-A012-M09C2025-02-20
03663136009445Hexanium® ACIFAC2-A012-M07C2025-02-20
03663136009452Hexanium® ACIFAC2-A012-M05C2025-02-20
03663136009469Hexanium® ACIFAC2-A012-S11C2025-02-20
03663136009476Hexanium® ACIFAC2-A012-S09C2025-02-20
03663136009483Hexanium® ACIFAC2-A012-S07C2025-02-20
03663136009490Hexanium® ACIFAC2-A012-S05C2025-02-20
03663136009261Hexanium® ACIFAC2-A012-L11L2025-02-19

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Primary DI, Brand, Company table
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03662663136709Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHTO2026-03-17
03662663136723Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHTO2026-03-17
00888867531659Arthrex®ARTHREX, INC.HTO2026-03-16
00888867531666Arthrex®ARTHREX, INC.HTO2026-03-16
00888867531673Arthrex®ARTHREX, INC.HTO2026-03-16
00888867531697Arthrex®ARTHREX, INC.HTO2026-03-16
00888867531703Arthrex®ARTHREX, INC.HTO2026-03-16
00888867531710Arthrex®ARTHREX, INC.HTO2026-03-16
00843575120205Primo™ Acetabular SystemB-ONE ORTHO, CORP.HTO2026-02-11
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00843575120236Primo™ Acetabular SystemB-ONE ORTHO, CORP.HTO2026-02-11
00843575120243Primo™ Acetabular SystemB-ONE ORTHO, CORP.HTO2026-02-11
00843575120250Primo™ Acetabular SystemB-ONE ORTHO, CORP.HTO2026-02-11
00843575120267Primo™ Acetabular SystemB-ONE ORTHO, CORP.HTO2026-02-11
00843575120274Primo™ Acetabular SystemB-ONE ORTHO, CORP.HTO2026-02-11
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