PULLUP® Fixation Device

GUDID B04816104120

VALERIS MEDICAL LLC

Ligament bone anchor

• Primary Device ID: B04816104120
• NIH Device Record Key: 8d61cac9-4e8d-4d41-8616-689ebfb2f76e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PULLUP® Fixation Device
• Version Model Number: 01
• Company DUNS: 079444554
• Company Name: VALERIS MEDICAL LLC
• 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: true
• 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
HIBCC	B04816104120 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151004

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: 4
• Public Version Date: 2019-01-08
• Device Publish Date: 2016-03-14

Devices Manufactured by VALERIS MEDICAL LLC

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• 00818614021638 - apollo: 2020-12-28 apollo 4.5mm drill
• 00818614021645 - apollo: 2020-12-28 apollo 5.5mm Drill
• 00818614021652 - titan: 2020-12-28 Beath Pin 2.4mm x 240mm
• 10818614021352 - Apollo: 2020-08-17 apollo Medial with Needles
• 10818614021369 - Apollo: 2020-08-17 apollo Medial with Needles, 5.5mm
• 10818614021376 - Apollo: 2020-08-17 apollo Medial with Needles, 6.5mm
• 00818614021508 - BoneCam: 2020-08-12 BoneCam 2.9mm Drill