LUPINE 210704

GUDID 10886705001033

DEPUY MITEK, LLC

Tendon/ligament bone anchor, bioabsorbable

• Primary Device ID: 10886705001033
• NIH Device Record Key: 11756805-a4ad-4465-8fbb-575cfd55d902
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LUPINE
• Version Model Number: 210704
• Catalog Number: 210704
• Company DUNS: 190572854
• Company Name: DEPUY MITEK, LLC
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10886705001033 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040827

FDA Product Code

• MAI: Fastener, fixation, biodegradable, soft tissue

Sterilization

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

[10886705001033]

Ethylene Oxide

[10886705001033]

Ethylene Oxide

[10886705001033]

Ethylene Oxide

[10886705001033]

Ethylene Oxide

[10886705001033]

Ethylene Oxide

[10886705001033]

Ethylene Oxide

[10886705001033]

Ethylene Oxide

[10886705001033]

Ethylene Oxide

[10886705001033]

Ethylene Oxide

[10886705001033]

Ethylene Oxide

[10886705001033]

Ethylene Oxide

[10886705001033]

Ethylene Oxide

[10886705001033]

Ethylene Oxide

[10886705001033]

Ethylene Oxide

[10886705001033]

Ethylene Oxide

[10886705001033]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-03-12
• Device Publish Date: 2025-03-04

On-Brand Devices [LUPINE]

• 10886705001545: LUPINE Spiral Fluted Drill Bit Reusable Instrument
• 10886705001460: LUPINE AWL
• 10886705001040: 210705
• 10886705001033: 210704