TightFix Interference Screw 9mm DFX0002T

GUDID 00854629006116

DUNAMIS MEDICAL, LLC

Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile

• Primary Device ID: 00854629006116
• NIH Device Record Key: 81165252-8f58-4252-9a5b-0f9798d70f49
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TightFix Interference Screw 9mm
• Version Model Number: DFX0002T
• Catalog Number: DFX0002T
• Company DUNS: 079471560
• Company Name: DUNAMIS MEDICAL, LLC
• Device Count: 1
• DM Exempt: true
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 877.454.2186
• Email: info@dunamismedical.com
• Phone: 877.454.2186
• Email: info@dunamismedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00854629006116 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151220

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-04-11

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