PULLUP® Fixation Device

GUDID B04816104120

VALERIS MEDICAL LLC

Ligament bone anchor Ligament bone anchor Ligament bone anchor Ligament bone anchor Ligament bone anchor Ligament bone anchor Ligament bone anchor Ligament bone anchor Ligament bone anchor Ligament bone anchor Ligament bone anchor Ligament bone anchor Ligament bone anchor Ligament bone anchor Ligament bone anchor Ligament bone anchor Ligament bone anchor Ligament bone anchor Ligament bone anchor Ligament bone anchor Ligament bone anchor Ligament bone anchor Ligament bone anchor Ligament bone anchor Ligament bone anchor Ligament bone anchor Ligament bone anchor Ligament bone anchor Ligament bone anchor Ligament bone anchor Ligament bone anchor Ligament bone anchor Ligament bone anchor Ligament bone anchor Ligament bone anchor Ligament bone anchor Ligament bone anchor Ligament bone anchor Ligament bone anchor Ligament bone anchor Ligament bone anchor Ligament bone anchor Ligament bone anchor Ligament bone anchor Ligament bone anchor Ligament bone anchor 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

• 00818614021560 - BoneCam: 2020-12-28 BoneCam Angled Reusable Surgical Drill Guide
• 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