FDA.reportPublic FDA data

Fixone Instrument

Primary DI
08800039100700
Brand
Fixone Instrument
Company
AJU PHARM. CO., LTD.
Model
Fixone.I.I-T8090
Device description
This device is used to drill a hole when inserting Fixone Interference screw.
Published
2025-01-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
08800039100700PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800039100700088000391007008800039100700

GMDN Terms#

Term, Definition table
TermDefinition
Bone tap, reusableA surgical instrument designed for cutting internal threads into bone, so that the threads facilitate the insertion of bone screws (not included). The screws may be used to anchor bone fragments, fixtures and/or other devices to the bone. It is typically manually rotated and consists of a metal shaft with a helical thread which may be cannulated or intersected with longitudinal cutting grooves. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
963422810
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800039100021Fixone Biocomposite AnchorBAB-45003ch2025-01-06
08800039100038Fixone Biocomposite AnchorBAB-55002dh2025-01-06
08800039100045Fixone Biocomposite AnchorBAB-55003ch2025-01-06
08800039100083Fixone Biocomposite AnchorKAB-55001ca2025-01-06
08800039100212Fixone Biocomposite Interference ScrewIAB-80025a2025-01-06
08800039100229Fixone Biocomposite Interference ScrewIAB-90025a2025-01-06
08800039100236Joinix Cannula SystemACS60072a2025-01-06
08800039100335Fixone Biocomposite AnchorSAL-30002i2025-01-06
08800039100380Fixone Biocomposite AnchorNAB-47502d2025-01-06
08800039100465Fixone All Suture AnchorFAS-1652803jw2025-01-06
08800039100502Fixone All Suture AnchorFAF-24615802ig2025-01-06
08800039100571Fixone Hybrid AnchorKAP-47501ca2025-01-06
08800039100601Fixone Hybrid AnchorKAP-55001ca2025-01-06
08800039100618Fixone InstrumentFixone.I.B-Awl450ak2025-01-06
08800039100625Fixone InstrumentFixone.I.B-Awl550ak2025-01-06
08800039100632Fixone InstrumentFixone.I.B-A/T450a2025-01-06
08800039100649Fixone InstrumentFixone.I.B-A/T550a2025-01-06
08800039100656Fixone InstrumentFixone.I.S-D/B3002025-01-06
08800039100663Fixone InstrumentFixone.I.S-D/G3002025-01-06
08800039100670Fixone InstrumentFixone.I.SL-D3002025-01-06

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00840286860109Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.LXH2026-07-09
00840286860116Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.LXH2026-07-09
10705034647463N/AMedos International SàrlLXH2026-07-09
B382SD49400B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
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B382SD49419B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD49420B0Surgical DirectSurgical Direct, Inc.LXH2026-07-09
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B382SD500020Surgical DirectSurgical Direct, Inc.LXH2026-07-09
B382SD500030Surgical DirectSurgical Direct, Inc.LXH2026-07-09