Sterile bone screw

GUDID 08800071019022

OSTEONIC CO.,Ltd.

Tendon/ligament bone anchor, non-bioabsorbable

• Primary Device ID: 08800071019022
• NIH Device Record Key: 199ed043-6716-49cb-87a9-27164a842e74
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sterile bone screw
• Version Model Number: PIS0825-PK
• Company DUNS: 688999370
• Company Name: OSTEONIC CO.,Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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	08800071019022 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202883

FDA Product Code

• MBI: Fastener, Fixation, Nondegradable, Soft Tissue

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-07-13
• Device Publish Date: 2021-07-05

On-Brand Devices [Sterile bone screw]

• 08800071019077: PIS1030-PK
• 08800071019060: PIS1025-PK
• 08800071019053: PIS0930-PK
• 08800071019046: PIS0925-PK
• 08800071019039: PIS0830-PK
• 08800071019022: PIS0825-PK
• 08800071019015: PIS0730-PK
• 08800071019008: PIS0725-PK