Signex

GUDID 08800071034308

OSTEONIC CO.,Ltd.

Orthopaedic bone screw (non-sliding)

• Primary Device ID: 08800071034308
• NIH Device Record Key: 46366a81-4ad0-4726-b53f-447538a22bad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Signex
• Version Model Number: S1B.35150
• Company DUNS: 688999370
• Company Name: OSTEONIC CO.,Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800071034308 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243469

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[08800071034308]

Moist Heat or Steam Sterilization

[08800071034308]

Moist Heat or Steam Sterilization

[08800071034308]

Moist Heat or Steam Sterilization

[08800071034308]

Moist Heat or Steam Sterilization

[08800071034308]

Moist Heat or Steam Sterilization

[08800071034308]

Moist Heat or Steam Sterilization

[08800071034308]

Moist Heat or Steam Sterilization

[08800071034308]

Moist Heat or Steam Sterilization

[08800071034308]

Moist Heat or Steam Sterilization

[08800071034308]

Moist Heat or Steam Sterilization

[08800071034308]

Moist Heat or Steam Sterilization

[08800071034308]

Moist Heat or Steam Sterilization

[08800071034308]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2025-07-09
• Device Publish Date: 2025-07-01

On-Brand Devices [Signex]

• 08809595971038: S1C.45100
• 08809539694924: S1D.35800
• 08809539694917: S1D.35750
• 08809539694900: S1D.35700
• 08809539694894: S1D.35650
• 08809539694887: S1D.35600
• 08809539694870: S1D.35550
• 08809539694863: S1D.35500
• 08809539694856: S1D.35480
• 08809539694849: S1D.35460
• 08809539694832: S1D.35450
• 08809539694825: S1D.35440
• 08809539694818: S1D.35420
• 08809539694801: S1D.35400
• 08809539694795: S1D.35380
• 08809539694788: S1D.35360
• 08809539694771: S1D.35340
• 08809539694764: S1D.35320
• 08809539694757: S1D.35300
• 08809539694740: S1D.35280
• 08809539694733: S1D.35260
• 08809539694726: S1D.35240
• 08809539694719: S1D.35220
• 08809539694702: S1D.35200
• 08809539694696: S1D.35180
• 08809539694689: S1D.35160
• 08809539694627: S1F.35800
• 08809539694610: S1F.35750
• 08809539694603: S1F.35700
• 08809539694597: S1F.35650
• 08809539694580: S1F.35600
• 08809539694573: S1F.35550
• 08809539694566: S1F.35500
• 08809539694559: S1F.35480
• 08809539694542: S1F.35460
• 08809539694535: S1F.35450
• 08809539694528: S1F.35440
• 08809539694511: S1F.35420
• 08809539694504: S1F.35400
• 08809539694498: S1F.35380
• 08809539694481: S1F.35360
• 08809539694474: S1F.35340
• 08809539694467: S1F.35320
• 08809539694450: S1F.35300
• 08809539694443: S1F.35280
• 08809539694436: S1F.35260
• 08809539694429: S1F.35240
• 08809539694412: S1F.35220
• 08809539694405: S1F.35200
• 08809539694399: S1F.35180