FDA.reportPublic FDA data

Inion Hexalon™ Instrumentation

Primary DI
M224INS92039
Brand
Inion Hexalon™ Instrumentation
Company
Inion Oy
Model
1
Catalog number
INS-9203
Device description
Guide wire 38 cm
Published
2020-05-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
FZXGuide, Surgical, Instrument
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZXGuide, Surgical, InstrumentGeneral, Plastic Surgery1
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06438408002564PrimaryGS10
M224INS92039SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06438408002564064384080025646438408002564

GMDN Terms#

Term, Definition table
TermDefinition
Surgical drill guide, reusableA manual surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone); some types are also intended for guiding bone-coring instruments (e.g., keel punch). It is designed in a tubular form or with guiding holes and may have serrations at its distal end to enable firm placement on hard tissue surfaces (it is not bored into the tissue); it can have a handle or be held by another device (e.g., orthopaedic jig), and typically allows protection of the surrounding soft tissue during surgery. It is typically made of metal and may have graduations along its length; it is not custom-made for a specific patient. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
367994657
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
true
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
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
00840606188128Ventana ASPINAL ELEMENTS, INC.LXH2026-07-13
B382SD9141791400Surgical DirectSurgical Direct, Inc.LXH2026-07-13
B382SD9142211000Surgical DirectSurgical Direct, Inc.LXH2026-07-13
00199150075034Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-10
07640177820907Neo Medical Pedicle screw kitNeo Medical SALXH2026-07-10
G079PDG2000Advantage-C Ti3D, Cervical InterbodyIntelivation, LLCFZX2026-07-10
00190446924838Arsenal FootTrilliant Surgical, LLCLXH2026-06-24
00190446948063Arsenal FootTrilliant Surgical, LLCFZX2026-06-24
00190446948186Arsenal FootTrilliant Surgical, LLCFZX2026-06-24
00190446948445Arsenal FootTrilliant Surgical, LLCFZX2026-06-24
00190446948452Arsenal FootTrilliant Surgical, LLCFZX2026-06-24
00190446948469Arsenal FootTrilliant Surgical, LLCLXH2026-06-24
00190446948476Arsenal FootTrilliant Surgical, LLCLXH2026-06-24
00840067212189TrellOss®-A SANEXXT SPINE, LLCLXH2026-06-24
00840067212196TrellOss®-A SANEXXT SPINE, LLCLXH2026-06-24
00840067212202TrellOss®-A SANEXXT SPINE, LLCLXH2026-06-24
00840067212219TrellOss®-A SANEXXT SPINE, LLCLXH2026-06-24
00840067212226TrellOss®-A SANEXXT SPINE, LLCLXH2026-06-24
00840067212233TrellOss®-A SANEXXT SPINE, LLCLXH2026-06-24
00840067212240TrellOss®-A SANEXXT SPINE, LLCLXH2026-06-24
00840067212257TrellOss®-A SANEXXT SPINE, LLCLXH2026-06-24
00840067212264TrellOss®-A SANEXXT SPINE, LLCLXH2026-06-24
00840067212271TrellOss®-A SANEXXT SPINE, LLCLXH2026-06-24
00840067212288TrellOss®-A SANEXXT SPINE, LLCLXH2026-06-24
00840067212295TrellOss®-A SANEXXT SPINE, LLCLXH2026-06-24
00840067212301TrellOss®-A SANEXXT SPINE, LLCLXH2026-06-24
08806162109382AnyPlus®GS Medical Co., Ltd.FZX2026-01-28
08806162109399AnyPlus®GS Medical Co., Ltd.FZX2026-01-28
08800322742945PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18
08800322742952PYXIS 3D Titanium Cervical Cage SystemGS Medical Co., Ltd.LXH2025-12-18