FDA.reportPublic FDA data

Inion ACL™ Instrumentation

Primary DI
M224INS93519
Brand
Inion ACL™ Instrumentation
Company
Inion Oy
Model
1
Catalog number
INS-9351
Device description
Graft preparation station base
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
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06438408002854PrimaryGS10
M224INS93519SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06438408002854064384080028546438408002854

GMDN Terms#

Term, Definition table
TermDefinition
Graft preparation station baseA non-sterile component device of a graft preparation station designed to provide a stable platform for the operator when preparing and pretensioning a graft prior to implantation. It is available in a variety of sizes and typically consists of a flat base onto which the graft is positioned, clamped and tensioned with selected posts, clamps and tensioning devices that are fixed to this device. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
367994657
Device count
1
DM exempt
true
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
06438408012815Inion CompressOn™ / Inion FreedomScrew™ Instrument1IFS-90672026-08-07
06438408012822Inion CompressOn™ / Inion FreedomScrew™ Instrument1IFS-90682026-08-07
06438408012839Inion CompressOn™ Instrument1IFS-90692026-08-07
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995323592V. MuellerSTERIS Deutschland GmbHLXH2026-09-25
00840606186223ALIF Disc PrepSPINAL ELEMENTS, INC.LXH2026-09-25
00840606186230ALIF Disc PrepSPINAL ELEMENTS, INC.LXH2026-09-25
00840606186261ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00840606186278ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00840606186285ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00840606187381ALIFSPINAL ELEMENTS, INC.LXH2026-09-25
00843193112699Prodisc C InstrumentCentinel Spine, LLCLXH2026-09-25
00843193112705Prodisc C InstrumentCentinel Spine, LLCLXH2026-09-25
07630040795166Surgical Manual InstrumentMedacta International SALXH2026-09-25
07630542792359Surgical Manual InstrumentMedacta International SALXH2026-09-25
20845854655501Argo KnotlessConmed CorporationLXH2026-09-25
20845854655518Argo KnotlessConmed CorporationLXH2026-09-25
00810130207541MSIModern Surgical Instruments LLCLXH2026-09-24
00810130207558MSIModern Surgical Instruments LLCLXH2026-09-24
00840606185929PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606185936PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606186773PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606186780PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606187237PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606187244PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00840606187251PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
00885556854778Cadence Total Ankle SystemSmith & Nephew, Inc.LXH2026-09-24
07899258601670Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-09-24
B7685215250Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2026-06-19
B7683434130Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2026-04-23
B7685216220Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-13
B7685111560Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-03
B768521135180Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-03
B7685216060Buxton BioMedicalBUXTON BIOMEDICAL, INC.LXH2025-11-03