5.5 X 24mm Citrefix XPress System

GUDID 00810027270887

Acuitive Technologies, Inc.

Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable

• Primary Device ID: 00810027270887
• NIH Device Record Key: c448efd9-3aa0-40a9-8af8-28cfbd4ce794
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 5.5 X 24mm Citrefix XPress System
• Version Model Number: 70-810-5524
• Company DUNS: 074645634
• Company Name: Acuitive Technologies, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: true
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 201-661-2680
• Email: mpoggie@acuitivetech.com
• Phone: 201-661-2680
• Email: mpoggie@acuitivetech.com
• Phone: 201-661-2680
• Email: mpoggie@acuitivetech.com
• Phone: 201-661-2680
• Email: mpoggie@acuitivetech.com
• Phone: 201-661-2680
• Email: mpoggie@acuitivetech.com
• Phone: 201-661-2680
• Email: mpoggie@acuitivetech.com
• Phone: 201-661-2680
• Email: mpoggie@acuitivetech.com
• Phone: 201-661-2680
• Email: mpoggie@acuitivetech.com
• Phone: 201-661-2680
• Email: mpoggie@acuitivetech.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810027270887 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203334

FDA Product Code

• MAI: Fastener, Fixation, Biodegradable, 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: 2022-07-25
• Device Publish Date: 2022-07-15

Devices Manufactured by Acuitive Technologies, Inc.

• 00810027271471 - Citrelock ACL 1.1mm K-Wire: 2024-03-07
• 00810027270436 - Citrefix 2.9mm Inserter: 2023-07-03
• 00810027270443 - Citrefix 3.5mm Inserter: 2023-07-03
• 00810027270450 - Citrefix 4.5mm Inserter: 2023-07-03
• 00810027270467 - Citrefix 5.5mm Inserter: 2023-07-03
• 00810027270474 - Citrefix 2.9mm Drill: 2023-07-03
• 00810027270481 - Citrefix 3.5mm Drill: 2023-07-03
• 00810027270498 - Citrefix 4.5mm Drill: 2023-07-03