FDA.reportPublic FDA data

Fixone Instrument

Primary DI
08800039100663
Brand
Fixone Instrument
Company
AJU PHARM. CO., LTD.
Model
Fixone.I.S-D/G300
Device description
Instrument used to mark or guide the implant or another instrument to the surgical site.
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
08800039100663PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800039100663088000391006638800039100663

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
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
08800039100670Fixone InstrumentFixone.I.SL-D3002025-01-06
08800039100687Fixone InstrumentFixone.I.SL-G3002025-01-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809986489425LnK Spinal Instrument SystemL&K BIOMED CO. ,LTD.LXH2026-08-19
08809986489432LnK Spinal Instrument SystemL&K BIOMED CO. ,LTD.LXH2026-08-19
M9432002230000Liberty SISpinal Simplicity, LLCLXH2026-08-19
00198506093937ELMED INCORPORATEDELMED INCORPORATEDLXH2026-08-18
00198506094194ELMED INCORPORATEDELMED INCORPORATEDLXH2026-08-18
00810130207534MSIModern Surgical Instruments LLCLXH2026-08-18
00810198920345General InstrumentsTheraMicro, LLCLXH2026-08-18
00810198920352TeKForceTheraMicro, LLCLXH2026-08-18
00810198920376TeKForceTheraMicro, LLCLXH2026-08-18
00850078396396ActivaScrew™ Cannulated COM Single-Use Accessory Kit 3.5/4.0/4.5 mm(1054)Eca Medical InstrumentsLXH2026-08-18
08053782781652Bioplan Instruments KitBRM EXTREMITIES SRLLXH2026-08-18
08057717553635BRM BIOPLAN INSTRUMENTBRM EXTREMITIES SRLLXH2026-08-18
08057717553642BRM BIOPLAN INSTRUMENTBRM EXTREMITIES SRLLXH2026-08-18
08057717553659BRM BIOPLAN INSTRUMENTBRM EXTREMITIES SRLLXH2026-08-18
08057717553666BRM BIOPLAN INSTRUMENTBRM EXTREMITIES SRLLXH2026-08-18
08057717553673BRM BIOPLAN INSTRUMENTBRM EXTREMITIES SRLLXH2026-08-18
08057717553680BRM BIOPLAN INSTRUMENTBRM EXTREMITIES SRLLXH2026-08-18
08057717553697BRM BIOPLAN INSTRUMENTBRM EXTREMITIES SRLLXH2026-08-18
08057717553703BRM BIOPLAN INSTRUMENTBRM EXTREMITIES SRLLXH2026-08-18
08057717553710BRM BIOPLAN INSTRUMENTBRM EXTREMITIES SRLLXH2026-08-18
08057717553727BRM BIOPLAN INSTRUMENTBRM EXTREMITIES SRLLXH2026-08-18
08057717553734BRM BIOPLAN INSTRUMENTBRM EXTREMITIES SRLLXH2026-08-18
08057717553741BRM BIOPLAN INSTRUMENTBRM EXTREMITIES SRLLXH2026-08-18
08057717553758BRM BIOPLAN INSTRUMENTSBRM EXTREMITIES SRLLXH2026-08-18
08800104097980Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.LXH2026-08-18
08800322750834PYXIS 3D Titanium Cage SystemGS Medical Co., Ltd.LXH2026-08-18
08800322758106PYXIS 3D Titanium Cage SystemGS Medical Co., Ltd.LXH2026-08-18
08800322758113PYXIS 3D Titanium Cage SystemGS Medical Co., Ltd.LXH2026-08-18
08800322759523QUASAR Standalone ACIF SystemGS Medical Co., Ltd.LXH2026-08-18
08800322759530QUASAR Standalone ACIF SystemGS Medical Co., Ltd.LXH2026-08-18